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Topical amethocaine gel for pain relief of heel prick blood sampling: a randomised double blind controlled trial.

BACKGROUND: Heel prick blood sampling is a commonly performed and painful procedure in the newborn infant. Use of a topical local anaesthetic does not relieve this pain. A 4% w/w amethocaine gel (Ametop) reduces the pain of venepuncture in the newborn but has not been tried with heel pricks. AIM: To investigate the effect of topical amethocaine gel on the pain of heel prick in the newborn infant. DESIGN: Randomised, double blind, placebo controlled trial. SUBJECTS: Sixty newborn infants, gestation 28-42 weeks (median 36), postnatal age 1-16 days (median 5) undergoing routine heel prick blood sampling. METHODS: A 1.5 g portion of 4% w/w amethocaine gel or placebo was applied to the skin under occlusion for one hour, then wiped away. Heel prick blood sampling with a spring loaded lance was performed five minutes later. The procedure was videotaped and pain assessed at one second intervals using an adaptation of the neonatal facial coding system (NFCS). No or minimal pain was defined as a cumulative score of less than 5 (out of 15) in the three seconds after firing of the lance and as lack of a cry in the first five seconds. RESULTS: In terms of a low NFCS core and lack of cry (p = 0.12) 20 of 30 (67%) in the amethocaine group and 13 of 29 (45%) in the placebo group had no or minimal pain in response to the heel prick. The median cumulative NFCS score over the three seconds after firing the lance was 3 (interquartile range 0-6) in the amethocaine group compared with 5 (interquartile range 1-10) in the placebo group (p = 0.07). These differences are not significant. CONCLUSIONS: Topical amethocaine gel does not have a clinically important effect on the pain of heel prick blood sampling and its use for this purpose cannot therefore be recommended. Alternative approaches to the relief of pain from this procedure should be explored.

Anesthetics, Local↗

Uptake of vitamin A in buccal mucosal cells after topical application of retinyl palmitate: a randomised, placebo-controlled and double-blind trial.

Retinoids have been reported to produce regressions in metaplastic changes of the mucosal epithelium. In order to define the role of these micronutrients in the prevention of squamous metaplasia of the oral cavity, it is necessary to measure their uptake in target tissues such as the buccal mucosal epithelium. We demonstrated in a trial that retinyl palmitate applied topically via a toothpaste is taken up by buccal mucosal cells in young healthy volunteers. In the randomised, parallel-designed, placebo-controlled and double-blind trial, forty volunteers divided in two groups cleaned their teeth either with a placebo toothpaste or a retinyl palmitate-containing toothpaste (1 mg/g) for 56 d. Buccal mucosal cells samples were taken from the healthy volunteers during the retinyl palmitate application and the following wash-out phase to determine the concentration of retinyl palmitate and retinol by HPLC. Supplementary blood samples were taken from the volunteers on days 0 and 56 to investigate changes in plasma retinyl palmitate and retinol concentrations. Results from only thirty participants (sixteen placebo and fourteen treated subjects) were used in the statistical evaluation as the remaining sample results were spoiled by a technical defect during the HPLC analysis. A significant (P<0.05) uptake of retinyl palmitate in buccal mucosal cells after 7 d and a significant (P<0.05) increase of plasma retinol after 17 d was demonstrated in our present study. The uptake of retinyl palmitate and the following hydrolysis to retinol led to an enrichment of vitamin A in buccal mucosal cells.

Absorption↗

Systemic antibiotics versus topical treatments for chronically discharging ears with underlying eardrum perforations.

BACKGROUND: Chronic suppurative otitis media (CSOM) causes ear discharge and impairs hearing. OBJECTIVES: To compare systemic antibiotics and topical antiseptics or antibiotics (excluding steroids) for treating chronically discharging ears with an underlying eardrum perforation (CSOM). SEARCH STRATEGY: The Cochrane ENT Disorders Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 1, 2005), MEDLINE (January 1951 to March 2005), EMBASE (January 1974 to March 2005), LILACS (January 1982 to March 2005), AMED (1985 to March 2005), CINAHL (January 1982 to March 2005), OLDMEDLINE (January 1958 to December 1965) PREMEDLINE, Metadatabase of registers of ongoing trials (mRCT), and article references. SELECTION CRITERIA: Randomised controlled trials; any systemic versus topical treatment (excluding steroids); participants with CSOM. DATA COLLECTION AND ANALYSIS: One author assessed eligibility and quality, extracted data, entered data into RevMan; two authors provided a second assessment of titles and abstracts, and inputted where there was ambiguity. We contacted investigators for clarifications. MAIN RESULTS: Nine trials (833 randomised participants; 842 analysed participants or ears). CSOM definitions and severity varied; some included mastoid cavity infections, other diagnoses, or complications. Methodological quality varied; generally poorly reported, follow-up short, handling of bilateral disease inconsistent. Topical quinolone antibiotics were better than systemic antibiotics at clearing discharge at 1-2 weeks: relative risks (RR) were, 3.21 (95% confidence interval (CI) 1.88 to 5.49) using systemic non-quinolone antibiotics (2 trials, N = 116), and 3.18 (1.87 to 5.43) using systemic quinolone (3 trials, N = 175); or 2.75 (1.38 to 5.46) in favour of systemic plus topical quinolone over systemic quinolone alone (2 trials, N = 90). No statistically significant benefit was seen at 2-4 weeks for topical non-quinolone antibiotic (without steroids) or topical antiseptic over systemic antibiotics (mostly non-quinolones), but numbers were small: one trial tested topical non-quinolones (N = 31); two tested antiseptics (N = 152). No benefit of adding systemic to topical treatment at 1-2 weeks was detected either, although evidence was limited (three trials, N = 204). Evidence regarding safety was generally weak. Adverse events reported were generally mild, although hearing worsened by ototoxicity (damaging auditory hair cells) was seen with chloramphenicol drops (non-quinolone antibiotic). AUTHORS' CONCLUSIONS: Topical quinolone antibiotics can clear aural discharge better than systemic antibiotics; topical non-quinolone antibiotic (without steroids) or antiseptic results are less clear. Evidence regarding safety was weak. Further studies should clarify topical non-quinolones and antiseptic effectiveness, assess longer-term outcomes (for resolution, healing, hearing, or complications), and include further safety assessments, particularly to clarify the risks of ototoxicity and whether there may be fewer adverse events with topical quinolones than other topical or systemic treatments.

Administration, Oral↗

Techniques for pelvic surgery in subfertility.

BACKGROUND: Since the introduction of in-vitro fertilisation (IVF) tubal surgery has been less frequently undertaken as a technique to improve fertility in women with damaged fallopian tubes. There are various surgical techniques that can be used to repair blocked or damaged fallopian tubes. OBJECTIVES: To evaluate the role of tubal surgery in the management of tubal infertility and to evaluate surgical techniques for the treatment of tubal infertility. SEARCH STRATEGY: This review has drawn on the search strategy developed for the Menstrual Disorders and Subfertility Group. We identified relevant trials from the Cochrane Menstrual Disorders and Subfertility Group Specialised Register (searched up to July 2005) and Cochrane Central Register of Controlled Trials (CENTRAL). The following databases were searched using the OVID platform: 1. MEDLINE (1966 to July 2005); 2. EMBASE (1980 to July 2005). SELECTION CRITERIA: All randomised controlled trials investigating the following topics on infertility surgery technique as follows were included.1) The role of infertility surgery versus no treatment.2) The role of infertility surgery versus alternative treatments.3) The role of magnification.4) The role of the CO2 laser at infertility surgery. 5) The role of operative laparoscopy to perform infertility surgery. 6) Any other intervention regarding surgical technique investigated by RCT. DATA COLLECTION AND ANALYSIS: Data were extracted independently by the first two authors. Differences of opinion were recognised and resolved by consensus. Two by two tables were generated for each trial for the dichotomous outcome of pregnancy and the effects on pregnancy rate of each study is expressed as an odds ratio with 95% confidence intervals. MAIN RESULTS: Seven randomised control trials were identified. No RCTs comparing infertility surgery versus no treatment or alternative treatments were found. There was no RCT found investigating the use of magnification for tubal surgery. There was no evidence for or against the use of a CO2 laser compared with standard techniques for adhesiolysis (OR for pregnancy 1.07, 95% CI 0.40 to 2.87) or salpingostomy (OR for pregnancy 1.38, 95% CI 0.47 to 4.05) from two RCTs. One RCT randomised women for salpingostomatolysis by laparotomy and laparoscopy using the classic approach or the one suture technique. There was no evidence of benefit or disadvantage when laparoscopy was compared to laparotomy. The OR for bilateral tubal patency was 1.32 (95% CI 0.55 to 3.22) and unilateral tubal patency OR was 0.82 (95% CI 0.29 to 2.29). The pregnancy rate was not reported. There was no evidence of benefit or disadvantage from two RCTs assessing the use of a prosthesis at salpingostomy compared with non-use (combined odds of pregnancy (term) in group using the prosthesis as compared to the control (OR for pregnancy at term 1.17, 95% CI 0.47 to 2.93). There was no evidence of benefit or disadvantage difference in one RCT comparing Cuff versus Bruhat technique for salpingostomy One RCT compared two methods of salpingostomy (OR for pregnancy rate ( intrauterine) 1.02, 95% CI 0.22 to 4.61). One RCT showed no evidence of benefit or disadvantage for the use of thermocoagulation or electrocoagulation at adhesiolysis, odds for pregnancy rate between the two groups OR 0.87 (95% CI 0.51 to 1.46). AUTHORS' CONCLUSIONS: From these limited data there is no evidence of benefit or disadvantage of tubal surgery versus no treatment or alternative treatments. Likewise there is no evidence of advantage or disadvantage of using microsurgery over standard techniques; laparoscopic approach over laparotomy; the use of CO2 laser; or electrocoagulation over thermocoagulation. Randomised controlled trials should be undertaken to determine the role of tubal surgery versus no treatment or alternative treatments. Randomised controlled trials should be undertaken to determine the role at tubal surgery of magnification, laparoscopic approach, the use of lasers or electrocoagulation.

Fallopian Tube Diseases↗

Topical insulin in wound healing: a randomised, double-blind, placebo-controlled trial.

Two studies were carried out to assess the relative roles of insulin and zinc in the acceleration of wound healing. In the first study, six diabetic and five non-diabetic human volunteers had two uniform cuts created, one on each forearm. One forearm wound was treated with topical regular insulin (Iletin-II) and the other with normal saline four times a day until healed. Treatment was double-blind and forearms were assigned randomly. The wounds treated with insulin healed 2.4 +/- 0.8 days faster than the wounds treated with saline (P < 0.001 by paired t-test). Zinc is used to crystallise insulin. When wounds are treated with insulin, they are therefore also being treated with zinc. If insulin accelerates wound healing, it is not clear if the increase in the rate of healing would be due to insulin (a known growth factor), the zinc it contains, or a combination of the two. The second study used a randomised, double-blind, placebo-controlled design to compare the efficacy of insulin with that of a solution containing the same amount of zinc in accelerating the healing of standardised wounds in rats and humans. Although these pilot investigations did not have the power to define the relative roles of insulin and zinc with accuracy, the results suggest that zinc does play a role in the wound healing process. It is concluded that topical insulin accelerates wound healing in humans. More importantly, however, this study describes a method of creating uniform wounds in humans acceptable to an institutional review board, thus solving one of the major impediments to the scientific evaluation of human wound healing.

Administration, Cutaneous↗

Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children.

BACKGROUND: OME is common and may cause hearing loss with associated developmental delay. Treatment remains controversial. The effect of both systemic and intra-nasal steroids on effusions has been assessed by randomised controlled trials. OBJECTIVES: To examine evidence for or against treating children with hearing loss associated with OME with systemic or topical nasal steroids. SEARCH STRATEGY: Searches were conducted in February 2000. We searched the Cochrane Controlled Trials Register using the terms 'otitis-media', 'otitis media with effusion', 'glue ear', or 'OME', and 'steroids', 'glucocorticoids, synthetic', 'glucocorticoids, topical', 'anti-inflammatory agents, steroidal'. EMBASE and MEDLINE were also searched for additional information. SELECTION CRITERIA: Randomised controlled trials of oral and topical nasal steroids, either alone or in combination with another agent such as an antibiotic, were included. EXCLUSIONS: publications in abstract form only since adequate appraisal was not possible; uncontrolled, non-randomised or retrospective studies; studies reporting outcomes with ears (rather than children) as the unit of analysis. DATA COLLECTION AND ANALYSIS: Data were extracted from the published reports by the two authors independently (CCB and JH van der V) using standardised data extraction forms and methodology. The methodological quality of the included studies were independently assessed by the two authors using the scheme described in the Cochrane Handbook. Dichotomous results were expressed as an odds ratio using a fixed effects model together with the 95% confidence intervals. Continuous data were analysed using the weighted mean difference in a fixed effects model. Tests for heterogeneity between studies were performed using a Mantel-Haenszel approach. In trials with a cross over design, post-crossover treatment data were not used. MAIN RESULTS: No study prospectively documented hearing loss associated with OME prior to randomisation. Follow up was short term. No serious or lasting side effects were reported in the four studies that did mention side effects. Most comparisons involved small numbers of subjects. The odds ratio for OME persisting after short term follow up for children treated with oral steroids plus antibiotic compared to control plus antibiotic was 0.32 (95% CI 0.20 to 0.52). However there was significant heterogeneity between studies (p<0.01). Trends favoured steroids for most other comparisons, but confidence intervals included unity. There was no evidence of benefit for steroid treatment in the longer term, and no study assessed effect of steroid treatment on language development. REVIEWER'S CONCLUSIONS: There is evidence that steroids combined with an antibiotic lead to a quicker resolution of OME in the short term. However, there is not evidence for long term benefit from treating hearing loss associated with OME with either oral or topical nasal steroids. These treatments are therefore not recommended at the present time. Future studies should document hearing loss associated with OME before the start of study treatment. Follow up should be longer and ideally include symptom, audiometry and developmental outcomes. Data should not be presented with ears as the unit of analysis.

Administration, Intranasal↗

TOIB Study. Are topical or oral ibuprofen equally effective for the treatment of chronic knee pain presenting in primary care: a randomised controlled trial with patient preference study. [ISRCTN79353052].

BACKGROUND: Many older people have chronic knee pain. Both topical and oral non- steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat this. Oral NSAIDS are effective, at least in the short term, but can have severe adverse effects. Topical NSAIDs also appear to be effective, at least in the short term. One might expect topical NSAIDs both to be less effective and to have fewer adverse effects than oral NSAIDs. If topical NSAIDs have fewer adverse effects this may outweigh both the reduction in effectiveness and the higher cost of topical compared to oral treatment. Patient preferences may influence the comparative effectiveness of drugs delivered via different routes. METHODS: TOIB is a randomised trial comparing topical and oral ibuprofen, with a parallel patient preference study. We are recruiting people aged 50 or over with chronic knee pain, from 27 MRC General Practice Research Framework practices across the UK. We are seeking to recruit 283 participants to the RCT and 379 to the PPS. Participants will be followed up for up to two years (with the majority reaching one year). Outcomes will be assessed by postal questionnaire, nurse examination, laboratory tests and medical record searches at one and two years or the end of the study. DISCUSSION: This study will provide new evidence on the overall costs and benefits of treating chronic knee pain with either oral or topical ibuprofen. The use of a patient preference design is unusual, but will allow us to explore how preference influences response to a medication. In addition, it will provide more information on adverse events. This study will provide evidence to inform primary care practitioners, and possibly influence practice.

Administration, Oral↗

Decrease of duration and symptoms in chemotherapy-induced oral mucositis by topical GM-CSF: results of a prospective randomised trial.

We have conducted a prospective controlled randomised clinical study testing for the efficacy of topical GM-CSF (molgramostim), as compared to the combined topical use of an antiseptic agent (povidone-iodine) and amphotericin B (AA) in patients with chemotherapy-induced mucositis World Health Organization (WHO) grades I-III. 31 patients (17 females, 14 males) developing oral mucositis following the administration of 5-fluorouracil (5-FU)-based chemotherapy were entered into the present trial. 15 patients were randomised to receive GM-CSF mouthwashes, whereas 16 patients were randomised into the control arm to receive AA. Reported history (P=0.6109) and grading of oral mucositis (2.1+/-0.7, respectively; P=0.9867) were balanced and equally distributed between the two groups. The mean size of lesions of oral mucositis was 1.5+/-0.6 cm (range: 0.7-2.5 cm) in the GM-CSF group and 1.2+/-0.5 cm (range: 0.5-2.5 cm) in the AA group (P=0.08), respectively. The mean number of oral mucositis lesions was 1.9+/-1.1 (range: 1-4) in the GM-CSF group and 2.1+/-1.2 (range: 1-4) in the AA group (P=0.63), respectively. None of the patients had previously received colony stimulating factors either topically or systemically. Treatment for oral mucositis was initiated on day 2.7+/-1.2 (range: day 1-8) after onset of symptoms in the GM-CSF group and on day 1.8+/-1.4 (range: day 1-3; P=0.11) in the AA group. The topical application of GM-CSF resulted in a significantly shorter duration and quicker resolution of oral mucositis, as compared to AA including both, pretreatment plus treatment periods (5.3+/-2.5 versus 8.1+/-1.5 days; P=0.0008) as well as the necessary duration of treatment needed until complete remission of lesions (2.8+/-0.7 versus 6.3+/-1.1 days; P<0.0001). A systemic effect of topical GM-CSF upon the number of peripheral blood leukocytes or granulocytes was excluded. We conclude that the topical application of GM-CSF by mouthwash significantly abbreviated the duration and relieved patients from symptoms of chemotherapy-induced mucositis and was superior to the topical application of AA.

Adult↗

Dressings and topical agents for arterial leg ulcers.

BACKGROUND: It is estimated that people in industrialised countries have a 1% chance of suffering from a leg ulcer at some time in their life. The majority of leg ulcers are associated with circulation problems; poor blood return in the veins causes venous ulcers (around 70% of ulcers) and poor blood supply to the legs causes arterial ulcers (around 25% of ulcers). Treatment of arterial leg ulcers is directed towards correcting the poor arterial blood supply, for example, by surgically correcting arterial blockages, and by supporting ulcer healing using topical agents (medicines in cream/ointment) and wound dressings. There are a large number of topical agents and wound dressings available and it is unclear what impact these have on ulcer healing. OBJECTIVES: To determine whether topical agents and wound dressings affect the rate of healing in arterial ulcers. To compare healing rates, costs and patient-centred outcomes between wound dressings and topical agents. SEARCH STRATEGY: Publications describing (or potentially describing) randomised controlled trials (RCTs), or controlled clinical trials (CCTs) of dressings and topical agents for arterial leg ulcers were sought through the Specialised Trials Registers of the Cochrane Wounds Group (last searched January 2002) and the Cochrane Peripheral Vascular Diseases Group (last searched April 2002). SELECTION CRITERIA: RCTs or CCTs (trials with non-randomised concurrent comparison groups) were eligible for inclusion. The participants had to have ulcers that were described as arterial, and the time to healing, proportion completely healed, or rate of reduction in ulcer area had to be reported. All wound dressings and topical agents were eligible for inclusion in this review. DATA COLLECTION AND ANALYSIS: Information on the participants' characteristics, the interventions, and outcomes, as well as data on the trial methods, such as blinding of patients and clinicians, and allocation concealment were extracted using a standardised data extraction form. MAIN RESULTS: One trial met the inclusion criteria. This small trial compared ketanserin ointment with vehicle alone, changed twice a day. The trial was too small and for too short a follow-up period to be able to determine whether there was any difference in healing rates. REVIEWER'S CONCLUSIONS: There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers. Inadequate description of the people in the one included trial means that the results cannot be easily applied to other clinical populations.

Administration, Topical↗

Comparative Efficacy and Safety of Adjunctive 0.015% Triamcinolone Acetonide Topical Spray With Lokivetmab Versus Lokivetmab Monotherapy as 'Reactive Therapy' for Canine Atopic Dermatitis: A Randomised, Single-Blinded, Controlled Preliminary Trial.

BACKGROUND: Lokivetmab is considered an effective systemic therapy for dogs with atopic dermatitis (AD); however, utilisation of lokivetmab with adjunctive topical anti-inflammatory glucocorticoids has not been investigated in canine AD. OBJECTIVES: To evaluate the efficacy and safety of the combination therapy of lokivetmab and 0.015% triamcinolone acetonide (TCA) spray in dogs with AD. ANIMALS: Twenty dogs with nonseasonal AD. MATERIALS AND METHODS: This study was a randomised, single-blinded (investigators only) 4-week controlled trial. Dogs were randomised to receive lokivetmab monotherapy or lokivetmab-TCA spray per manufacturer instructions. Clinical assessments included the Canine Atopic Dermatitis Extent and Severity Index, 4th iteration (CADESI-04), CADESI-04E (i.e., extracted erythema grade alone) and the 10-grade pruritus Visual Analog Scale (PVAS10) at Day (D)0, D14 and D28. Complete blood count and serum biochemical analysis were performed on D0 and D28. RESULTS: The median CADESI-04 and CADESI-04E scores in the lokivetmab-TCA group were significantly reduced on D14 (p&#x2009;<&#x2009;0.05 for both) and D28 (p&#x2009;<&#x2009;0.01 for both) compared to baseline; there were no significant differences in lesional scores at any time point for the lokivetmab monotherapy group. Lokivetmab-TCA significantly reduced CADESI-04E values compared to the lokivetmab monotherapy group on D28 (p&#x2009;=&#x2009;0.04). Both interventions significantly reduced PVAS10 scores on D14 and D28 compared to D0 (p&#x2009;<&#x2009;0.05 for both groups). CONCLUSIONS AND CLINICAL RELEVANCE: Topical application of TCA spray may be a useful and safe adjunctive therapy for systemic lokivetmab to alleviate pruritus and clinical lesions in the initial management of canine AD patients.

Animals↗

Cophenylcaine spray vs. placebo in flexible nasendoscopy: a prospective double-blind randomised controlled trial.

Practices vary across the UK on the use of topical preparation prior to flexible fibreoptic nasendoscopy. In this double-blind study, we randomised 98 patients to receive cophenylcaine or placebo nasal spray before flexible nasendoscopy. A visual analogue scale (1-100) was used to record pain, unpleasantness of taste and overall discomfort experienced. Overall, the procedure was associated with minimal pain and discomfort in both groups. There was no significant difference in pain or overall discomfort experienced between the two groups; however, the sensation of bad taste was significantly worse in the cophenylcaine group. In linear regression, factors that predicted the overall unpleasantness of the experience were primarily pain experienced and secondarily unpleasantness of taste. We conclude that the routine use of cophenylcaine for nasal preparation is not justified before flexible nasendoscopy.

Administration, Intranasal↗

Randomised controlled trial of ketorolac in the management of corneal abrasions.

PURPOSE: To evaluate the role of topical non-steroidal anti-inflammatory agents (NSAIDs) in the management of corneal abrasions with respect to symptoms and healing. METHODS: The study was designed as a prospective, single center, randomised, placebo controlled, double-blinded trial. Eighty-eight consecutive patients with non-infective, non-contact lens related traumatic or foreign body removal related corneal abrasions were recruited to this study. They were randomised into two groups. Both groups were given a single instillation of Gutt. cyclopentolate 0.5% followed by chloramphenicol eye ointment four times a day until the following day. In addition, the treatment group received topical Ketorolac trometamol 0.5% ophthalmic solution while the control group received placebo Liquifilm tears. Patients were assessed at presentation and about twenty-four hours later for subjective symptoms, abrasion size and any associated complications. RESULTS: There was no statistical difference in the two groups at base line and twenty-four hour follow-up when assessed for five subjective symptoms of pain, photophobia, grittiness, watering and blurring of vision. However, those receiving topical ketorolac required significantly less additional oral analgesics (p=0.001). There was no difference in the rate of healing. CONCLUSION: Use of topical ketorolac may be a useful adjunct in the management of corneal abrasions.

Administration, Topical↗

The use of patient-controlled transcutaneous electronic nerve stimulation (TENS) to decrease the discomfort of regional anaesthesia in dentistry: a randomised controlled clinical trial.

OBJECTIVE: To compare the use of topical anaesthesia and transcutaneous electronic nerve stimulation (TENS) as means of reducing the discomfort of inferior dental block injections. METHODS: One hundred adult dental patients received 2% lignocaine with 1:80,000 adrenaline for long buccal and inferior dental block anaesthesia. The long buccal injections were given first with no prior mucosal preparation. Patients received inferior dental blocks after one of the following mucosal preparations: (1) no pretreatment; (2) a 2 min application of 20% benzocaine topical anaesthetic; (3) application of patient-controlled TENS at the injection site. Patients scored injection discomfort after each administration on a 100 mm visual analogue scale. RESULTS: The discomfort of the long buccal injection did not differ between the three groups of patients (F2,97 = 1.0). There were significant differences in the pain scores for the inferior dental block injections (F2,97 = 5.3; p < 0.01). Injection discomfort following TENS was less than that following no pretreatment (p < 0.01) and after topical anaesthetic application (p < 0.05). The use of topical anaesthesia did not produce a significant change in injection discomfort compared with no pretreatment. CONCLUSION: The use of TENS reduces injection discomfort during inferior dental block anaesthesia.

Administration, Topical↗

Topical glyceryl trinitrate and eutectic mixture of local anaesthetics in children. A randomised controlled trial on choice of site and ease of venous cannulation.

One hundred and four children aged between 1 and 11 years were studied in a double-blind randomised controlled trial of glyceryl trinitrate ointment versus placebo, when used in addition to standard eutectic mixture of local anaesthetics cream. Each child received glyceryl trinitrate ointment on one hand and placebo on the other, and thus acted as his/her own control. A group of 30 children who received only the eutectic mixture on both hands (60 measurements) was also studied. The choice of site and ease of cannulation was scored. Skin colour and venous dilatation under the eutectic mixture were scored on a visual analogue scale. The addition of topical glyceryl trinitrate ointment to the standard eutectic mixture positively affected venous dilatation (p less than 0.01), choice of cannulation site (p less than 0.001), and ease of cannulation (p less than 0.001) of topical anaesthetic-treated skin.

Administration, Topical↗

Topical nonsteroidal anti-inflammatory gel for the prevention of peripheral vein thrombophlebitis. A double-blind, randomised, placebo-controlled trial in normal subjects.

A double-blind, randomised, placebo-controlled study was undertaken to determine whether topical application of a nonsteroidal anti-inflammatory gel to skin overlying peripheral vein cannula sites has a role in reducing the incidence or delaying the onset of peripheral vein thrombophlebitis. Fifty normal subjects had intravenous cannulae placed in right and left arms. Subjects were randomised to receive twice daily application of either active nonsteroidal anti-inflammatory gel or placebo gel to each cannula site. Cannula sites were observed and signs and symptoms of inflammation recorded up to 108 h. If any site had signs extending beyond 2 cm then the cannula was removed. Cannula sites that had 'active' gel applied had half the incidence of marked signs at 108 h (44% vs 22%, p less than 0.05). These results suggest that local application of topical nonsteroidal anti-inflammatory gel to cannula sites may have a significant role to play in the prevention of peripheral vein thrombophlebitis.

Administration, Topical↗

Comparative clinical trial of bifonazole solution versus selenium sulphide shampoo in the treatment of pityriasis versicolor.

38 patients were entered into a controlled randomised trial, comparing two forms of topical treatment for pityriasis versicolor. Diagnosis was made on clinical criteria and confirmed by direct microscopic examination of Parker Quink/KOH preparations. 20 patients were treated with bifonazole solution daily for 2 weeks. 18 patients were treated with 2.5% selenium sulphide shampoo daily for one week and weekly for six weeks. Mycological examination showed that Malassezia furfur was present in all patients prior to treatment. At the end of the trial, 1 patient (5%) treated with bifonazole and 4 patients (22%) of those treated with selenium sulphide shampoo showed the presence of the fungus in the skin. This study demonstrates that bifonazole solution is an effective and well-tolerated form of treatment for pityriasis versicolor. A 2-week course of bifonazole solution was as effective as a 7-week course of selenium sulphide shampoo in eradicating the disease and had a lower relapse rate at 4 weeks.

Administration, Topical↗

Antipsychotic drugs for non-affective psychosis during pregnancy and postpartum.

BACKGROUND: Antipsychotics are commonly prescribed for women suffering psychotic illnesses during pregnancy and the postpartum period. The potential adverse consequences of these different options are multiple and complex, impacting on the foetus, neonate, infant and early development of the child as well as the woman herself. OBJECTIVES: To establish whether the benefits of taking antipsychotic drugs outweigh the risks for pregnant or post partum women. SEARCH STRATEGY: The Cochrane Schizophrenia Group's Register (January 2003) was searched in order to identify all published trials of women during pregnancy or the postpartum period. We inspected all references of all identified studies. If any studies had been found, the first authors of each included study would have been contacted. SELECTION CRITERIA: Randomised controlled clinical trials investigating the effects of any type of antipsychotic drug compared with any other treatment option (including standard psychosocial care, any other antipsychotic drug, or an alternative therapy such as electro-convulsive therapy or cognitive behavioural therapy) and involving pregnant women and/or women during the postpartum period diagnosed with a non-affective psychotic disorder. DATA COLLECTION AND ANALYSIS: Citations, and where possible, abstracts were independently inspected by reviewers and the papers ordered were scrutinised and quality assessed. Data would have been extracted independently by at least two reviewers. Binary outcomes were to have been analysed using Relative Risks (RR) and their 95% Confidence Intervals (CI). MAIN RESULTS: We found no trials that met the broad inclusion criteria. REVIEWERS' CONCLUSIONS: Current guidelines and clinical practice for the use of antipsychotic drugs in women with non-affective disorders during pregnancy and postpartum are not based on evidence from randomised controlled trials. Although ethical concerns have to date precluded the use of randomised controlled trials to address this research topic, the continued use of antipsychotic drugs in this group of women in itself poses significant clinical and ethical problems. Evidence is required from large pragmatic trials that reflect routine clinical practice, examine a broad range of outcomes and accurately quantify risks and benefits to both mothers and their offspring, so that comparison between different treatment options can be made.

Antipsychotic Agents↗