PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Randomised controlled trials as topic”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 145 records · Page 8Linked to original sources

A randomised, double-blind, placebo-controlled, comparative study of topical skin analgesics and the anxiety and discomfort associated with venous cannulation.

OBJECTIVES: To compare the effect of topical skin anaesthetic agents on the discomfort and anxiety associated with venous cannulation. DESIGN: Randomised, double-blind, placebo-controlled, within subject, volunteer trial. METHODS: 20 healthy volunteers underwent venous cannulation on three separate occasions having received topical skin application of either 4% amethocaine gel (Ametop), 5% eutectic mixture of lidocaine and prilocaine (EMLA) or E45 cream (placebo). Visual analogue and verbal rating scales were used to assess pain and anxiety associated with the venous cannulation, and anticipated anxiety for future cannulation, under each drug condition. RESULTS: Subjects were aged 22-53 years (mean 32.8 years). The mean visual analogue scores (VAS) for discomfort were found to be significantly lower (p< 0.001) with Ametop (VAS = 18mm) and EMLA (VAS = 29mm) compared with the control (VAS = 38mm). There was a positive correlation (R2 = 72%, p<0.001) between discomfort and the predicted anxiety if cannulation was to be repeated with the same cream. With the placebo a positive correlation (R2 = 19.8%, p = 0.05) was found between the level of anxiety before cannulation and the level of discomfort recorded. CONCLUSIONS: Ametop and EMLA topical anaesthetic agents produce effective skin analgesia for venous cannulation. The use of topical analgesia can reduce perceived anxiety about future cannulation procedures. This has application in the management of anxious patients undergoing intravenous sedation, suggesting that topical analgesia prior to venous cannulation may significantly aid anxiolysis.

Administration, Cutaneous↗

Techniques for pelvic surgery in subfertility.

BACKGROUND: Since the advent of in-vitro fertilisation (IVF) the role of infertility surgery has diminished. This type of surgery is still however widely performed.and there are many different surgical techniques that can be used to repair blocked or damaged Fallopian tubes. Most evidence in this area comes from uncontrolled series. OBJECTIVES: To evaluate surgical techniques for the treatment of tubal infertility (adhesiolysis, salpingostomy, surgery for proximal tubal occlusion, reversal of sterilisation). SEARCH STRATEGY: This review has drawn on the search strategy developed for the Subfertility Group as a whole. Relevant trials were identified from the Group's Register of Controlled Trials. SELECTION CRITERIA: All randomised controlled trials investigating an aspect of infertility surgery technique. Non-randomised data were included for the following topics 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. Non- RCT data were excluded if :- i) The treatment and control groups differed significantly ii) The treatment and control groups were operated by a different team or in a different institute iii) Where pregnancy outcome data were not given. DATA COLLECTION AND ANALYSIS: Data were extracted independently by the first 2 authors. Differences of opinion were registered and resolved by consensus with the senior author (RL). 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: 1) INFERTILITY SURGERY VERSUS NO TREATMENT One non RCT compared open adhesiolysis versus no treatment and found significantly more pregnancies in the treatment group compared with the control group. 2) INFERTILITY SURGERY VERSUS ALTERNATIVE TREATMENTS. No RCTs investigated the role of infertility surgery compared with In vitro fertilisation (IVF). There were no studies comparing tubal surgery for proximal tubal occlusion versus hysteroscopic or radiologically controlled recannulation. 3) MAGNIFICATION FOR INFERTILITY SURGERY There was a non significant reduction in pregnancy rate when the operating microscope (magnification x4-x16) was used rather than Loupes (magnification x2-x4.5) in the only RCT to study this. One RCT randomised patients to microsurgery versus a macrosurgical technique involving a prosthesis. There were more pregnancies in the microsurgery group, but this was not significant, and the trial consisted of only 18 participants. All the non-RCT studies comparing microsurgery with macrosurgery had a historical control group. Meta-analysis of studies investigating the role of magnification for adhesiolysis and for salpingostomy revealed a statistically significant increase in pregnancy rates and reduction in ectopic pregnancy rates for microsurgery versus macrosurgery for both procedures. For reversal of sterilisation there was a significant improvement in term pregnancy rates, and a non significant reduction in ectopic rates There was no significant difference between microsurgical and macrosurgical treatment of proximal tubal occlusion for any outcome. 4) THE USE OF LASER AT INFERTILITY SURGERY Two RCTs investigated the use of the CO2 laser at infertility surgery. There was no significant difference in pregnancy outcome after adhesiolysis, or salpingostomy. Two non randomised studies also investigated the role of the laser. Overall there was no significant difference using the CO2 laser compared with standard techniques for adhesiolysis, salpingostomy or reversal of sterilisation. 5) LAPAROSCOPIC INFERTILITY SURGERY Four studies investigated the use of laparoscopic techniques for infertility surgery. There were no RCTs. One study compared laparoscopic versus open

Fallopian Tube Diseases↗

Topical amethocaine gel in the newborn infant: how soon does it work and how long does it last?

AIM: To explore the time of onset and duration of action of topical amethocaine gel in the newborn infant. DESIGN: A randomised double blind placebo controlled trial. SUBJECTS: Thirty six infants were studied after 30 minutes application and 36 after 60 minutes application. A total of 56 infants (gestation 27-42 weeks, weight 0. 79-4.1 kg) were studied in the first two weeks after delivery. METHOD: 1.5 g amethocaine or placebo was applied to the dorsum of either foot, occluded, and then left for 30 or 60 minutes. Local anaesthesia was assessed by observing the cutaneous withdrawal response to graded nylon filaments (von Frey hairs). If there was a difference between feet in filament thickness required to elicit a response, the infant was studied in an identical manner at hourly intervals until the difference had disappeared. RESULTS: Evidence of local anaesthetic action of amethocaine was seen in 23 of 36 (64%) infants after 30 minutes and 26 of 36 (72%) infants after 60 minutes application (no significant difference). Evidence of local anaesthetic action was independent of gestation and order of testing. Amethocaine responders showed a significantly deeper anaesthetic action than placebo responders. The median duration of action was 1.5 hours (range 0.5-3.5) after 30 minutes and three hours (range 1-5) after 60 minutes (p<0.001). CONCLUSION: Topical amethocaine gel has a local anaesthetic action after 30 minutes application, but application for 60 minutes results in longer duration of action.

Anesthetics, Local↗

Randomised, controlled trial of spirometric changes in elderly people receiving timolol or betaxolol as initial treatment for glaucoma.

AIM: To investigate respiratory and cardiovascular side effects in elderly people in the first 12 months after commencing topical beta antagonists. METHODS: 40 patients (mean age 74 years) were recruited to a randomised, masked study. Spirometry, pulse, and blood pressure were recorded before, 1 month, and 12 months after starting topical therapy with either timolol 0.5% twice daily or betaxolol 0.5% twice daily. RESULTS: After 1 month five of 20 patients allocated timolol and three of 20 given betaxolol had discontinued it for respiratory reasons, not always accompanied by symptoms. There were no significant differences in changes in mean values of spirometry, pulse, or blood pressure between groups. No further changes were made in therapy for respiratory reasons in the following year. One patient suffered a hypotensive stroke within 2 days of starting timolol. CONCLUSIONS: By performing spirometry before starting topical beta antagonist therapy and repeating it after 1 month most patients at risk of respiratory impairment can be identified.

Aged↗