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Results for “Randomised Controlled Trial”

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PubMed2006

Six sessions of manual therapy increase knee flexion and improve activity in people with anterior knee pain: a randomised controlled trial.

QUESTION: What are the effects of manual therapy on pain, range of motion, and activity in patients with anterior knee pain? DESIGN: Randomised controlled trial. PARTICIPANTS: Thirty-eight ambulatory care patients (one dropout) with anterior knee pain. INTERVENTION: The experimental intervention consisted of six sessions of manual therapy, while the control intervention was to remain on the waiting list for two weeks. OUTCOME MEASURES: Pain was measured using the Patellofemoral Pain Severity Questionnaire. Active knee flexion and extension was measured from photographs. Activity was measured by having the participants step up and down a 15 cm step, leading with the painful leg as many times as they could in a 60 second period. Measurements were taken before and after intervention by a blinded assessor. RESULTS: The experimental group decreased their pain by -8 mm (95% CI to 1 p =0.08) and pain on stairs by-10, (95% CI -22 to 2 p = 0.10) compared with the control group. They increased their active knee flexion by 10 deg (95% CI TO 16, p = 0.004) and and the number of steps in 60 seconds by 5 (95% CI 2 TO 8, p = 0.001) compared with the control group. CONCLUSION: Manual therapy is effective improving knee flexion and stair climbing i patients with anterior knee pain. There is a trend towards a small improvement in pain.

Adolescent↗

PubMed2006

Mime therapy improves facial symmetry in people with long-term facial nerve paresis: a randomised controlled trial.

QUESTION: What is the effect of mime therapy on facial symmetry and severity of paresis in people with facial nerve paresis? DESIGN: Randomised controlled trial. PARTICIPANTS: 50 people recruited from the Outpatient department of two metropolitan hospitals with facial nerve paresis for more than nine months. INTERVENTION: The experimental group received three months of mime therapy consisting of massage, relaxation, inhibition of synkinesis, and co-ordination and emotional expression exercises. The control group was placed on a waiting list. OUTCOME MEASURES: Assessments were made on admission to the trial and three months later by a measurer blinded to group allocation. Facial symmetry was measured using the Sunnybrook Facial Grading System. Severity of paresis was measured using the House-Brackmann Facial Grading System. RESULTS: After three months of mime therapy, the experimental group had improved their facial symmetry by 20.4 points (95% CI 10.4 to 30.4) on the Sunnybrook Facial Grading System compared with the control group. In addition, the experimental group had reduced the severity of their paresis by 0.6 grade (95% CI 0.1 to 1.1) on the House-Brackmann Facial Grading System compared with the control group. These effects were independent of age, sex, and duration of paresis. CONCLUSION: Mime therapy improves facial symmetry and reduces the severity of paresis in people with facial nerve paresis.

Adult↗

PubMed2002

Randomised controlled trials and publication trends in periodontal research during 1980-2000.

OBJECTIVES: To study publication trends, as well as the number and proportion of randomised controlled trials covering different areas of periodontal research (RCT-Ps). MATERIAL AND METHODS: The study was based on Medline searches (MeSH terms) for the period 1980- 2000. The RCT-Ps (n = 675) were examined for relevance for different areas of periodontal research, journals of publication, and the countries of origin. RESULTS: In periodontal research the annual number of publications had increased from 162 in 1980 to 440 in 2000. Moreover, clinical trials in periodontal research (CT-Ps) had increased more than 10-fold, and RCT-Ps more than 15-fold. More than 4 out of 10 RCT-Ps covered the areas 'periodontal surgery' and 'gingivitis and plaque treatment or prevention'. More than 6 out of 10 RCT-Ps in total and more than 8 out of 10 RCT-Ps about 'periodontal surgery', were published in two different journals. U.S.A was the most common country of origin of RCT-Ps, contributing to almost 4 out of 10 RCT-Ps during 1988-2000. CONCLUSION: The annual number of RCT-Ps increased substantially during 1980-2000, and a few clinical research areas predominated. Future research should give priority to areas where clinical evidence is scarce and where high-quality RCT-Ps are most needed.

Dental Research↗

PubMed2006

Ethnicity questions and antenatal screening for sickle cell/thalassaemia [EQUANS] in England: a randomised controlled trial of two questionnaires.

UNLABELLED: Concepts allied to ethnicity are increasingly coming under question as legitimate variables for use in health research. A randomised controlled trial of two ethnicity screening questions for ascertaining risk of carrying genes associated with sickle cell and thalassaemia illustrates the challenges and limitations of assessing an association of social constructs and genetic statuses. OBJECTIVES: To evaluate two candidate ethnicity screening questions in antenatal screening programmes in low, mixed and high sickle cell prevalence areas, and to identify time taken in administration of the questions by use of the following measures: (1) Proportions of respondents with missing ethnicity data and/or significant changes in ethnic/family origins upon re-interview. (2) Numbers of carriers of clinically significant haemoglobin disorders missed by ethnicity screening questions. (3) Time taken to explain screening question for sickle cell disease (SCD)/thalassaemia and obtain ethnic/family origins. (4) Proportion of clients providing usable ethnic/family origins data. (5) Reported ethnic/family origins in pregnant women at first booking with midwife. DESIGN: Ten-month (September 2002-June 2003) questionnaire study with random allocation to two self-administered ethnicity questions, comparison with laboratory results and results from re-interview. The settings were antenatal booking clinics in four geographical areas of England of varying expected foetal prevalence of SCD: very high (29.75 per 10,000 pregnancies); high (8.2); mixed high and low (1.29); and low (0.18). The subjects were 4,559 pregnant women at first booking with midwife. RESULTS: Proportions of respondents with missing ethnicity data and/or significant changes in ethnic/family origins upon re-interview were 4.33% (CI 2.63-6.68%) for a category-based question and 9.45% (CI 6.86-12.61%) for a binary plus open-ended question. Proportions of carriers missed were 5.74% (CI 2.34-11.46%) and 9.71% (CI 4.75-17.13%) by category-based and binary plus open-ended questions, respectively. Average time taken to ascertain ethnic/family origins for screening was between 2.17 and 5.12 minutes in different areas, and up to 15 minutes at the 95th centile. Usable ethnicity screening data was missing in 2.94% of instances. Errors in interpretation or missing data were 3.2% for a category-based question and 4.71% for a binary plus open-ended ethnicity question. Ethnicity Question A produces fewer cases of missing or misinterpreted data (p < 0.001). CONCLUSIONS: A category-based ethnicity screening question was more effective than a binary plus open-ended question. Using the more effective question, 5.74% (CI 2.34-11.46%) of significant haemoglobinopathies will be missed in a selective screening programme, and 4.33% (CI 2.63-6.68%) of replies to an ethnicity screening question will be unreliable when compared to information given upon re-interview. In specific carefully circumscribed situations, namely, in antenatal screening for sickle cell and thalassaemia, it is possible to measure the degree of association between social constructs of ethnicity and health status in a manner that may help in effecting policy decisions.

Adult↗

PubMed1996

Routine obstetric ultrasound examinations in South Africa: cost and effect on perinatal outcome--a prospective randomised controlled trial.

OBJECTIVE: To compare routine midtrimester with selective obstetric ultrasonography concerning the Health Service cost and the effect on perinatal outcome. DESIGN: A randomised controlled trial. SETTING: Urban area served by Tygerberg Hospital, a tertiary referral centre in South Africa. PARTICIPANTS: Pregnant patients without risk factors for congenital anomalies referred for ultrasonography between 18 and 24 weeks of gestation. INTERVENTION: Between 18 and 24 weeks, a level one ultrasound examination was performed on study patients only. Except for the routine scan, both groups received the same antenatal care and could be referred later for additional scans as judged by their clinicians. MAIN OUTCOME MEASURES: Overall adverse perinatal outcome and use of antenatal and neonatal services. RESULTS: The groups did not differ significantly in their use of antenatal and neonatal services except for a greater number of ultrasound scans in the study group. More suspected postdate pregnancies occurred in control patients, as well as more amniocenteses for confirmation of lung maturity. More babies of low birthweight were born in the study group. The incidence of overall or major adverse perinatal outcome was comparable. Routine ultrasonography was accompanied by a considerable increase in costs. CONCLUSION: Selective use of obstetric ultrasonography did not increase the use of antenatal and neonatal services. Not routinely performing ultrasonography has led to considerable Health Service savings without increasing the risk for adverse perinatal outcome. It saved 75% of selected patients a referral to an ultrasound unit. Specific problems related to inaccurate gestational age determination need to be addressed.

Adult↗

PubMed2006

Membrane sweeping and prevention of post-term pregnancy in low-risk pregnancies: a randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of membrane sweeping at 41 weeks for the prevention of post-term pregnancy. DESIGN: A multicentre randomised controlled trial. SETTING: Fifty-one primary care midwifery practices in the Netherlands. POPULATION: A total of 742 low-risk pregnant women at 41 weeks of gestation. METHODS: Participants were randomly assigned to serial sweeping of the membranes (every 48 hours until labour commenced up to 42 weeks of gestation) or no intervention. MAIN OUTCOME MEASURES: Post-term pregnancy (>or=42 weeks). Subgroup analyses were performed on nulliparous and parous women. Secondary outcomes included adverse effects. RESULTS: Serial sweeping of the membranes at 41 weeks decreased the risk of post-term pregnancy (87/375 [23%] versus 149/367 [41%]; relative risk [RR] 0.57, 95% CI 0.46-0.71; number needed to treat [NNT] 6 [95% CI 4-9]). Benefits were also seen in both subgroups (nulliparous: 57/198 [29%] versus 89/192 [46%]; RR 0.62 [95% CI 0.48-0.81]; NNT 6 [95% CI 4-12] and parous: 30/177 [17%] versus 60/175 [34%]; RR 0.49 [95% CI 0.34-0.73]; NNT 6 [95% CI 4-6]). Adverse effects were similar in both the groups except for uncomplicated bleeding, which was reported more frequently in the sweeping group. Other obstetric outcomes and indicators of neonatal morbidity were similar in both groups. There were two perinatal deaths in each group. CONCLUSIONS: Membrane sweeping at 41 weeks can substantially reduce the proportion of women with post-term pregnancy.

Adult↗

PubMed1997

Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial.

OBJECTIVES: To assess whether intraoperative intravascular volume optimisation improves outcome and shortens hospital stay after repair of proximal femoral fracture. DESIGN: Prospective, randomised controlled trial comparing conventional intraoperative fluid management with repeated colloid fluid challenges monitored by oesophageal Doppler ultrasonography to maintain maximal stroke volume throughout the operative period. SETTING: Teaching hospital, London. SUBJECTS: 40 patients undergoing repair of proximal femoral fracture under general anaesthesia. INTERVENTIONS: Patients were randomly assigned to receive either conventional intraoperative fluid management (control patients) or additional repeated colloid fluid challenges with oesophageal Doppler ultrasonography used to maintain maximal stroke volume throughout the operative period (protocol patients). MAIN OUTCOME MEASURES: Time declared medically fit for hospital discharge, duration of hospital stay (in acute bed; in acute plus long stay bed), mortality, perioperative haemodynamic changes. RESULTS: Intraoperative intravascular fluid loading produced significantly greater changes in stroke volume (median 15 ml (95% confidence interval 10 to 21 ml)) and cardiac output (1.2 l/min (0.1 to 2.3 l/min)) than in the conventionally managed group (-5 ml (-10 to 1 ml) and -0.4 l/min (-1.0 to 0.2 l/min)) (P < 0.001 and P < 0.05, respectively). One protocol patient and two control patients died in hospital. In the survivors, postoperative recovery was significantly faster in the protocol patients, with shorter times to being declared medically fit for discharge (median 10 (9 to 15) days v 15 (11 to 40) days, P < 0.05) and a 39% reduction in hospital stay (12 (8 to 13) days v 20 (10 to 61) days, P < 0.05). CONCLUSIONS: Proximal femoral fracture repair constitutes surgery in a high risk population. Intraoperative intravascular volume loading to optimal stroke volume resulted in a more rapid postoperative recovery and a significantly reduced hospital stay.

Aged↗

PubMed1999

Effect on hospital attendance rates of giving patients a copy of their referral letter: randomised controlled trial.

OBJECTIVES: To investigate whether sending patients a copy of their referral letter can reduce non-attendance at outpatient departments. DESIGN: Blinded randomised controlled trial. SETTING: 13 general practices in Exeter, Devon. SUBJECTS: 2078 new consultant referrals from 26 doctors. MAIN OUTCOME MEASURES: Non-attendance at outpatient departments. RESULTS: The doctors excluded 117 (5.6%) referrals, and 100 (4.8%) received no appointment. Attendance data were available for 1857 of the 1861 patients sent an appointment (99.8%). The receipt of a copy letter had no effect on the non-attendance rate: copy 50/912 (5.5%) versus control 50/945 (5.3%). CONCLUSION: Copy letters are ineffective in reducing non-attendance at outpatient departments.

Correspondence as Topic↗

PubMed2003

Compliance therapy: a randomised controlled trial in schizophrenia.

OBJECTIVE: To evaluate the efficacy of "compliance therapy" for improving adherence to prescribed drug treatment among patients with schizophrenia. DESIGN: Randomised controlled trial. SETTING: Urban catchment area psychiatric service. PARTICIPANTS: 94 consecutive admissions of patients with schizophrenia, 56 agreed to participate. INTERVENTION: Compliance therapy and non-specific counselling, each consisting of 5 sessions lasting 30-60 minutes. MAIN OUTCOME MEASURES: Compliance with drug treatment at one year; attitudes to treatment, symptomatology, insight, and quality of life at one year; length of "survival" in the community, bed days, and rehospitalisation rates at two years. RESULTS: Compliance therapy did not confer a major advantage over non-specific therapy in improving compliance at one year (43% (12/28) v 54% (15/28), difference -11% (95% confidence interval -37% to 15%) or in any of the secondary outcome measures-symptomatology, attitudes to treatment, insight, global assessment of functioning, and quality of life. CONCLUSION: Compliance therapy may not be of benefit to patients with schizophrenia. Attitudes to treatment at baseline predicted adherence one year later and may be a clinically useful tool.

Adolescent↗

PubMed1993

A randomised controlled trial of psychotherapy in patients with refractory irritable bowel syndrome.

Patients with chronic, refractory irritable bowel syndrome (n = 102) were entered into a randomised controlled trial of psychotherapy versus supportive listening. Independent physical and psychological assessments were carried out at the beginning and end of the 12-week trial. For women, psychotherapy was found to be superior to supportive listening, in terms of an improvement in both physical and psychological symptoms. There was a similar trend for men, but this did not reach significance. Following completion of the trial, patients in the control group were offered psychotherapy; 33 accepted and following treatment experienced a marked improvement in their symptoms; ten declined. At follow-up one year later, those patients who had received psychotherapy remained well, patients who had dropped out of the trial were unwell with severe symptoms, and most of the controls who declined psychotherapy had relapsed. This study shows that psychotherapy is feasible and effective in the majority of irritable bowel syndrome patients with chronic symptoms unresponsive to medical treatment.

Adult↗

PubMed2005

Cost-effectiveness of rehabilitation after an acute coronary event: a randomised controlled trial.

OBJECTIVE: To estimate the incremental effects on cost and quality of life of cardiac rehabilitation after an acute coronary syndrome. DESIGN: Open randomised controlled trial with 1 year's follow-up. Analysis was on an intention-to-treat basis. SETTING: Two tertiary hospitals in Sydney. INTERVENTION: 18 sessions of comprehensive exercise-based outpatient cardiac rehabilitation or conventional care as provided by the treating doctor. PARTICIPANTS: 113 patients aged 41-75 years who were self-caring and literate in English. Patients with uncompensated heart failure, uncontrolled arrhythmias, severe and symptomatic aortic stenosis or physical impairment were excluded. MAIN OUTCOME MEASURES: Costs (hospitalisations, medication use, outpatient visits, investigations, and personal expenses); and measures of quality of life. Incremental cost per quality-adjusted life year (QALY) saved at 1 year (this estimate combines within-study utility effects with reported 1-year risk of survival and treatment effects of rehabilitation on mortality). Sensitivity analyses around a base case estimate included alternative assumptions of no treatment effect on survival, 3 years of treatment effect on survival and variations in utility. RESULTS: The estimated incremental cost per QALY saved for rehabilitation relative to standard care was 42,535 US dollars when modelling included the reported treatment effect on survival. This increased to 70,580 US dollars per QALY saved if treatment effect on survival was not included. The results were sensitive to variations in utility and ranged from 19,685 US dollars per QALY saved to rehabilitation not being cost-effective. CONCLUSIONS: The effects on quality of life tend to reinforce treatment advantages on survival for patients having postdischarge rehabilitation after an acute coronary syndrome. The estimated base case incremental cost per QALY saved is consistent with those historically accepted by decision making authorities such as the Pharmaceutical Benefits Advisory Committee.

Adult↗

PubMed1999

Hospital in the home: a randomised controlled trial.

OBJECTIVES: To compare treatment of acute illness at home and in hospital, assessing safety, effect on geriatric complications, and patient/carer satisfaction. DESIGN: Randomised controlled trial. SETTING: A tertiary referral hospital affiliated with the University of New South Wales. PARTICIPANTS: 100 patients (69% older than 65 years) with a variety of acute conditions, who were assessed in the emergency department as requiring admission to hospital. INTERVENTIONS: Patients were allocated at random to be treated by a hospital-in-the-home (HIH) service in their usual residence or to be admitted to hospital. MAIN OUTCOME MEASURES: Geriatric complications (confusion, falls, urinary incontinence or retention, faecal incontinence or constipation, phlebitis and pressure areas), patient/carer satisfaction, adverse events, and death. RESULTS: There was a lower incidence of confusion (0 v. 20.4% [95% CI, 9.1%-31.7%]; P = 0.0005), urinary complications (incontinence or retention) (2.0% [95% CI, -1.8%, 5.8%] v. 16.3% [95% CI, 6.0%, 26.6%]; P = 0.01), and bowel complications (incontinence or constipation) (0 v. 22.5% [95% CI, 10.7%, 34.1%]; P = 0.0003) among HIH-treated patients. No significant difference in number of adverse events and deaths (to 28 days after discharge) in the two groups was found (although numbers were small). Patient and carer satisfaction was significantly higher in the HIH group. CONCLUSIONS: Home treatment appears to provide a safe alternative to hospitalisation for selected patients, and may be preferable for some older patients. We found high levels of both patient and carer satisfaction with home treatment.

Aged↗

PubMed2002

Routine examination of the newborn and maternal satisfaction: a randomised controlled trial.

OBJECTIVE: To determine whether the routine examination of the newborn by a midwife compared with a junior paediatrician (SHO) affects maternal satisfaction with this examination. METHODS: Randomised controlled trial: 826 mother and baby pairs in a district general hospital in south east England were randomised to a paediatric SHO or a midwife for the routine newborn examination. Maternal satisfaction with the examination was analysed in relation to intervention group, process, and background variables. RESULTS: Some 81% of mothers reported that they were satisfied or very satisfied with the newborn examination. Mothers assigned to a midwife were more satisfied with the newborn examination (crude odds ratio (OR) 0.54 (95% confidence interval (CI) 0.39 to 0.75), p < 0.001). However, after provision of health education during the examination, continuity of care provided, and history of miscarriage had been controlled for, status of examiner was no longer related to maternal satisfaction (adjusted OR 0.82 (95% CI 0.57-1.20), NS). The discussion of healthcare issues by the examiner (adjusted OR 0.49 (95% CI 0.34 to 0.70), p < 0.001) and continuity of care (adjusted OR 0.43 (95% CI 0.23 to 0.81), p < 0.01) were both related to enhanced satisfaction, and history of miscarriage (adjusted OR 1.61 (1.08 to 2.40), p < 0.05) was associated with lower maternal satisfaction with the newborn examination. Midwives (61%) were more likely than SHOs (33%) to discuss healthcare issues, such as feeding, sleeping, and skin care. CONCLUSIONS: Mothers were more likely to be satisfied with the newborn examination by a midwife than an SHO because midwives were more likely to discuss healthcare issues during the examination and were able to provide continuity of care. However, midwife examinations according to exclusion criteria agreed with trial midwives excluded half of all newborns, and criteria may have to be reconsidered for practice implementation.

Clinical Competence↗

PubMed2006

A survey of inclusion of the time element when reporting adverse effects in randomised controlled trials of cyclo-oxygenase-2 and tumour necrosis factor alpha inhibitors.

BACKGROUND: The adequacy of reporting the time element in adverse effects in articles on randomised clinical trials of cyclo-oxygenase-2 and tumour necrosis factor (TNF)alpha antagonists was surveyed. METHODS: Prominent rheumatology and general/internal medicine journals were searched for all randomised controlled trials published about cyclo-oxygenase-2 and TNFalpha inhibitor use in rheumatological diseases up to November 2005. Reporting of time to the occurrence of the adverse effects, the use of patient years as the time frame of the reported adverse effects and the use of annual standard incidence ratios based on the surveillance, epidemiology and end-results (SEER) programme when reporting neoplasms as potential adverse effects of TNFalpha antagonists were specifically tabulated. RESULTS: Only 23 of 70 (33%) of all articles gave the specific time of onset of an adverse effect. Nine studies used patient years to report the adverse effects and six studies used annual standard incidence ratios, using SEER, as the comparator. CONCLUSION: In reporting of adverse effects in randomised clinical trials, a particularly neglected issue is the reporting of the time dimension of adverse effects.

Antirheumatic Agents↗

PubMed2005

Transitional care facility for elderly people in hospital awaiting a long term care bed: randomised controlled trial.

OBJECTIVE: To assess the effectiveness of moving patients who are waiting in hospital for a long term care bed to an off-site transitional care facility. DESIGN: Randomised controlled trial. SETTING: Three public hospitals in Southern Adelaide. PARTICIPANTS: 320 elderly patients (mean age 83 years) in acute hospital beds (212 randomised to intervention, 108 to control). INTERVENTIONS: A transitional care facility where all patients received a single assessment from a specialist elder care team and appropriate ongoing therapy. MAIN OUTCOME MEASURES: Length of stay in hospital, rates of readmission, deaths, and patient's functional level (modified Barthel index), quality of life (assessment of quality of life), and care needs (residential care scale) at four months. RESULTS: From admission, those in the intervention group stayed a median of 32.5 days (95% confidence interval 29 to 36 days) in hospital. In the control group the median length of stay was 43.5 days (41 to 51 days) (95% confidence interval for difference 6 to 16 days). Patients in the intervention group took a median of 21 days (6 to 27 days) longer to be admitted to permanent care than those in the control group. In both groups few patients went home (14 (7%) in the intervention group v 9 (9%) in the control group). There were no significant differences in death rates (28% v 27%) or rates of transfer back to hospital (28% v 25%). CONCLUSIONS: For frail elderly patients who are awaiting a residential care bed transfer out of hospital to an off-site transitional care unit with focus on aged care "unblocks beds" without adverse effects.

Aged, 80 and over↗

PubMed2001

The effectiveness of exercise as an intervention in the management of depression: systematic review and meta-regression analysis of randomised controlled trials.

OBJECTIVE: To determine the effectiveness of exercise as an intervention in the management of depression. DESIGN: Systematic review and meta-regression analysis of randomised controlled trials obtained from five electronic databases (Medline, Embase, Sports Discus, PsycLIT, Cochrane Library) and through contact with experts in the field, bibliographic searches, and hand searches of recent copies of relevant journals. MAIN OUTCOME MEASURES: Standardised mean difference in effect size and weighted mean difference in Beck depression inventory score between exercise and no treatment and between exercise and cognitive therapy. RESULTS: All of the 14 studies analysed had important methodological weaknesses; randomisation was adequately concealed in only three studies, intention to treat analysis was undertaken in only two, and assessment of outcome was blinded in only one. The participants in most studies were community volunteers, and diagnosis was determined by their score on the Beck depression inventory. When compared with no treatment, exercise reduced symptoms of depression (standardised mean difference in effect size -1.1 (95% confidence interval -1.5 to -0.6); weighted mean difference in Beck depression inventory -7.3 (-10.0 to -4.6)). The effect size was significantly greater in those trials with shorter follow up and in two trials reported only as conference abstracts. The effect of exercise was similar to that of cognitive therapy (standardised mean difference -0.3 (95% confidence interval -0.7 to 0.1)). CONCLUSIONS: The effectiveness of exercise in reducing symptoms of depression cannot be determined because of a lack of good quality research on clinical populations with adequate follow up.

Data Collection↗

PubMed2004

Diamorphine for pain relief in labour : a randomised controlled trial comparing intramuscular injection and patient-controlled analgesia.

OBJECTIVES: To compare the efficacy of diamorphine administered by a patient-controlled pump (patient-controlled analgesia) with intramuscular administration for pain relief in labour. DESIGN: Randomised controlled trial. SETTING: The South Glasgow University Hospitals NHS Trust. SAMPLE: Primigravidae and multigravidae in labour at term (37-42 weeks). METHODS: Women were randomised in labour to the study (patient-controlled analgesia) or control group (intramuscular). Randomisation was achieved through a random permuted block design stratified by parity. Study group women were given a loading dose of 1.2 mg diamorphine intravenously and then attached to the pump. Control group women received intramuscular diamorphine as per hospital protocol. Participants were also given 3 mg of buccal Stemetil. Data were collected throughout labour and at six postnatal weeks. MAIN OUTCOME MEASURES: Analgesia requirements during labour and women's satisfaction with the method of pain relief. RESULTS: Women in the study group (patient-controlled analgesia) used significantly less diamorphine than women in the control group (intramuscular) but were significantly more likely to state that they were very dissatisfied with their use of diamorphine and were significantly more likely to opt out of the trial before the birth of the baby. The majority of women in both groups used other analgesia concurrent with diamorphine such as Entonox, aromatherapy or TENS. CONCLUSIONS: Patient-controlled analgesia administration of diamorphine for the relief of pain in labour offers no significant advantages over intramuscular administration. The results also suggest that diamorphine is a poor analgesic for labour pain irrespective of the mode of administration.

Analgesia, Patient-Controlled↗

PubMed2000

A randomised controlled trial of Prostar Plus for haemostasis in patients after coronary angioplasty.

OBJECTIVES: to clarify the efficacy and safety of Prostar Plus, a new percutaneous vascular surgical device (PVS) for vascular haemostasis. DESIGN: prospective randomised controlled trial. METHODS: a consecutive series of 60 patients were randomised to either PVS (n =30) or conventional manual compression ( n =30) following coronary angioplasty or stenting with femoral access using an 8-F sheath. RESULTS: PVS significantly shortened the time to haemostasis (10 s.d. 3 vs. 27 s.d. 9 min, p <0.001), ambulation (2.2 s.d. 0.9 vs. 11.0 s.d. 1.4 h, p <0.001), and discharge (2.2 s.d. 0.4 vs. 3.1 s.d. 0.7 days, p <0.01), compared with the manual compression group with no major complications. PVS also increased patient comfort assessed by using a visual-analogue scale method. Although these clinical benefits reduced the hospital cost ($1301 s. d. 248 vs. 1613 s.d. 460, p <0.05), the cost of the PVS device (approximately $350) cancelled the cost-saving benefit. CONCLUSIONS: this randomised study indicates that Prostar Plus is safe, more effective and comfortable than conventional manual compression.

Angioplasty, Balloon, Coronary↗