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Results for “Randomised Controlled Trial”

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PubMed1995

Nebulised amiloride in respiratory exacerbations of cystic fibrosis: a randomised controlled trial.

OBJECTIVE: To assess the benefit of nebulised amiloride added to the standard inpatient treatment of a respiratory exacerbation in cystic fibrosis. DESIGN: Prospective, randomised, double blind, placebo controlled trial. SUBJECTS: 27 cystic fibrosis patients (mean age 12.8 years). SETTING: Two hospitals in Leeds, UK. RESULTS: Both forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) showed improvements over the course of treatment, although there was no difference in respiratory function between the two groups at any of three time periods during the study. The time to reach peak FVC was significantly reduced in the amiloride group (4.2 v 7.6 days; 95% CI 0.4 to 6.4 days), but not in the time to reach peak FEV1 (5.7 v 7.9 days; 95% CI -1.2 to 5.6 days). CONCLUSIONS: Amiloride did not result in a greater overall improvement in respiratory function. There was a suggestion that it may have an effect on the rate of improvement, and thus may possibly influence the duration of treatment. This hypothesis deserves further evaluation.

Adolescent↗

PubMed2002

Intravaginal 400 microg misoprostol for pregnancy termination in cases of blighted ovum: a randomised controlled trial.

OBJECTIVE: To investigate the effectiveness and side effects of intravaginal misoprostol 400 micrograms compared with a placebo for facilitating complete abortion in cases of blighted ovum. DESIGN: A prospective randomised placebo-controlled trial. SETTING: Rajavithi Hospital, Thailand between 1 July 1998 and 31 January 1999. SAMPLE: Fifty-four pregnant women with gestations of up to 12 weeks whose diagnosis of blighted ovum had been made by transvaginal ultrasound. METHODS: The patients were assigned randomly into two equal groups; the study group received two tablets of vaginal misoprostol (200 micrograms/tablet), and the control group received two tablets of a vaginal placebo. RESULTS: The complete abortion rate was significantly higher in the women receiving misoprostol (63%) compared with those receiving the placebo (18.5%) (p < 0.05). Lower abdominal pain (74.1%) and fever (14.8%) were significantly higher in the study group than in the placebo group (22.2%) and (0%) respectively, (p < 0.05). CONCLUSION: Intravaginal 400 microg misoprostol is significantly more effective for termination of blighted ovum than placebo, but lower abdominal pain and fever are signifcantly higher in the misoprostol group.

Abortifacient Agents, Nonsteroidal↗

PubMed1998

Randomised, controlled trial of nasal continuous positive airway pressure in the extubation of infants weighing 600 to 1250 g.

AIM: To determine whether extubation to nasal continuous airway pressure (NCPAP) results in a greater proportion of infants remaining free of additional ventilatory support for one week after extubation compared with those extubated directly to headbox oxygen. METHODS: A randomised, controlled, clinical trial was conducted at the neonatal intensive care unit of the Royal Women's Hospital, Melbourne, of infants with birthweights between 600 and 1250 g, ventilated via an endotracheal tube for more than 12 hours, requiring less than 50% oxygen, a ventilator rate < or = 20/minute, considered by the clinical management team to be ready for extubation. Infants were randomly allocated either to NCPAP or to oxygen administered via a headbox. Success was defined by no requirement for additional ventilatory support over the week following extubation. Failure criteria were (i) apnoea; (ii) absolute increase in oxygen requirement greater than 15% above than required before extubation; or (iii) respiratory acidosis (pH < 7.25 with pCO2 > 6.67 kPa). RESULTS: Thirty one of 47 (66%) infants were successfully extubated to NCPAP compared with 18 of 45 (40%) for headbox oxygen. The increase in failure rate in the headbox group was due primarily to increased oxygen requirements in this group. Of the 27 who failed headbox oxygen, 26 were given a trial of NCPAP and 13 did not require endotracheal reintubation. There was no significant difference between the groups in the total number of days of assisted ventilation or the duration of inpatient stay. CONCLUSIONS: NCPAP applied prophylactically after endotracheal extubation reduces the incidence of adverse clinical events that lead to failure of extubation in the seven days after extubation. This reduction is clinically important. The benefits of NCPAP do not seem to be associated with an increased incidence of unwanted side effects.

Female↗

PubMed2006

Cognitive-behavioural therapy for severe and recurrent bipolar disorders: randomised controlled trial.

BACKGROUND: Efficacy trials suggest that structured psychological therapies may significantly reduce recurrence rates of major mood episodes in individuals with bipolar disorders. AIMS: To compare the effectiveness of treatment as usual with an additional 22 sessions of cognitive-behavioural therapy (CBT). METHOD: We undertook a multicentre, pragmatic, randomised controlled treatment trial (n=253). Patients were assessed every 8 weeks for 18 months. RESULTS: More than half of the patients had a recurrence by 18 months, with no significant differences between groups (hazard ratio=1.05; 95% CI 0.74-1.50). Post hoc analysis demonstrated a significant interaction (P=0.04) such that adjunctive CBT was significantly more effective than treatment as usual in those with fewer than 12 previous episodes, but less effective in those with more episodes. CONCLUSIONS: People with bipolar disorder and comparatively fewer previous mood episodes may benefit from CBT. However, such cases form the minority of those receiving mental healthcare.

Adult↗

PubMed2006

Effects of calcium supplementation on bone density in healthy children: meta-analysis of randomised controlled trials.

OBJECTIVES: To assess the effectiveness of calcium supplementation for improving bone mineral density in healthy children and to determine if any effect is modified by other factors and persists after supplementation stops. DESIGN: Meta-analysis. DATA SOURCES: Electronic bibliographic databases, hand searching of conference proceedings, and contacting authors for unpublished data. REVIEW METHODS: We included randomised placebo controlled trials of calcium supplementation in healthy children that lasted at least three months and had bone outcomes measured after at least six months of follow-up. Two reviewers independently extracted data and assessed quality. Meta-analyses predominantly used fixed effects models with outcomes given as standardised mean differences. RESULTS: We included 19 studies involving 2859 children. Calcium supplementation had no effect on bone mineral density at the femoral neck or lumbar spine. There was a small effect on total body bone mineral content (standardised mean difference 0.14, 95% confidence interval 0.01 to 0.27) and upper limb bone mineral density (0.14, 0.04 to 0.24). This effect persisted after the end of supplementation only at the upper limb (0.14, 0.01 to 0.28). There was no evidence that sex, baseline calcium intake, pubertal stage, ethnicity, or level of physical activity modified the effect. CONCLUSIONS: The small effect of calcium supplementation on bone mineral density in the upper limb is unlikely to reduce the risk of fracture, either in childhood or later life, to a degree of major public health importance.

Adolescent↗

PubMed1980

A randomised controlled trial of the effect of the provision of free school milk on the growth of children.

A randomised controlled study was carried out of the effect on growth of the provision of free milk supplements to schoolchildren aged 7 and 8. In selecting children for this study, the aim was to identify those whose socioeconomic circumstances might place them at a disadvantage for growth. Five hundred and eighty-one-children were selected from schools where a high proportion of the pupils received free school meals, and from families with four or more children. The subjects were randomly allocated to receive a third of a pint (190 ml) of free milk daily for six school terms or to a control group. The mean difference in height gain at the end of twenty-one-and-a-half months was 3% or 2.93 mm (P less than 0.05) in favour of the children provided with free milk. The mean difference in weight gain was 130 g (P greater than 0.05) in their favour. The height and weight gain associated with the provision of free mild was very small in the study population, and it is therefore likely that the benefit to growth of providing free milk for the whole unselected population of schoolchildren of these ages would be even smaller.

Animals↗

PubMed2003

Efficacy of knee tape in the management of osteoarthritis of the knee: blinded randomised controlled trial.

OBJECTIVES: To test the hypotheses that therapeutic taping of the knee improves pain and disability in patients with osteoarthritis of the knee and that benefits remain after stopping treatment. DESIGN: Randomised single blind controlled trial with three intervention arms (therapeutic tape, control tape, and no tape) of three weeks' duration and three week follow up. SETTING: Outcome assessment was performed in a university based laboratory. Taping interventions were applied by eight physiotherapists in metropolitan private practice. PARTICIPANTS: 87 patients with symptoms of knee osteoarthritis as defined by the American College of Rheumatology. MAIN OUTCOME MEASURES: Primary outcome measure was pain as measured by visual analogue scale and participant perceived rating of change. Secondary measures of pain and disability included the Western Ontario and MacMaster Universities osteoarthritis index, knee pain scale, and the SF-36. RESULTS: The therapeutic tape group reported a greater reduction in pain on all primary outcomes than either of the other two groups. A significant association was evident between intervention and change in pain at three weeks (P=0.000), with 73% (21/29) of the therapeutic tape group reporting improvement compared with 49% (14/29) of the control tape group and 10% (3/29) of the no tape group. Significantly greater improvement in pain and disability was observed on most secondary outcomes in the therapeutic tape group compared with the no tape group. Benefits of therapeutic tape were maintained three weeks after stopping treatment. CONCLUSIONS: Therapeutic knee taping is an efficacious treatment for the management of pain and disability in patients with knee osteoarthritis.

Bandages↗

PubMed2005

Systematic review and meta-analysis of randomised, controlled trials of the timing of chest radiotherapy in patients with limited-stage, small-cell lung cancer.

BACKGROUND: We undertook a systematic review and literature-based meta-analysis to determine whether the timing of chest radiotherapy may influence the survival of patients with limited-stage small-cell lung cancer (LS-SCLC). MATERIALS: Eligible randomised controlled clinical trials were identified according to the Cochrane Collaboration Guidelines, comparing different timing of chest radiotherapy in patients with LS-SCLC. Early chest irradiation was defined as beginning within 30 days after the start of chemotherapy. RESULTS: Considering all seven eligible trials, the overall survival at 2 or 5 years was not significantly different between early or late chest radiotherapy. When only trials were considered that used platinum chemotherapy concurrent with chest radiotherapy, a significantly higher 5-year survival was observed when chest radiotherapy was started within 30 days after the start of chemotherapy (2-year survival: OR: 0.73, 95% CI 0.51-1.03, P = 0.07; 5-year survival: OR: 0.64, 95% CI 0.44-0.92, P = 0.02). This was even more pronounced when the overall treatment time of chest radiotherapy was less than 30 days. CONCLUSIONS: There are indications that the 5-year survival rates of patients with LS-SCLC are in favour of early chest radiotherapy, with a significant difference if the overall treatment time of chest radiation is less than 30 days.

Carcinoma, Small Cell↗

PubMed2004

A randomised controlled trial of morphine versus phenobarbitone for neonatal abstinence syndrome.

BACKGROUND: The incidence of neonatal abstinence syndrome (NAS) has increased 10-fold over the last decade in Glasgow. In the Princess Royal Maternity Hospital, it now accounts for 17% of special care baby unit (SCBU) admissions. OBJECTIVE: To compare opiate replacement therapy (morphine sulphate) with the present standard treatment (phenobarbitone) for management of NAS. The primary study end point was duration of pharmaceutical treatment. Secondary end points were the requirement for additional drugs and the requirement for SCBU admission. DESIGN: Double blind, randomised controlled clinical trial. METHODS: Differential diagnoses were excluded, and two consecutive Lipsitz scores > 4 defined NAS requiring treatment. Infants were randomised to receive morphine sulphate or phenobarbitone. Treatments were identical in appearance, odour, and volume. Increments, decrements, and discontinuation of treatments were protocol driven. RESULTS: Seventy five infants participated. All mothers received opiate replacement therapy (methadone) during pregnancy and most used other drugs (n = 62, 83%). No significant difference in maternal drug use patterns was observed between treatment groups. Median treatment duration was four days shorter with opiate replacement (8 v 12 days, Mann-Whitney U test, p = 0.02). Phenobarbitone treated infants tended to require second line treatment (47% v 35%, chi(2) test, p = 0.11) and SCBU admission (62% v 30%, chi(2) test, p = 0.04) more often. CONCLUSIONS: Opiate replacement therapy appears to be superior for management of symptomatic NAS when maternal opiate use is prevalent. The shorter treatment duration and lower requirement for higher intensity nursing may have significant cost implications. Tailoring NAS treatment to local maternal drug use may result in similar benefits.

Double-Blind Method↗

PubMed1996

Randomised controlled trial of methyldopa and isradipine in preeclampsia--effects on uteroplacental and fetal hemodynamics.

This is a prospective randomised controlled study in 21 women admitted with preeclampsia in the third trimester. The mean arterial blood pressure decreased by 11.1 mmHg (95% confidence interval -14.9 to -7.3 mmHg) in the methyldopa group, and by 9.3 mmHG (95% confidence interval-14.4 to -4.2 mmHG) in the isradipine group. The maternal heart rate decreased by 6.9 beats per min (95% confidence interval -11.6 to -2.2 bpm) during methyldopa treatment, and by 2.5 beats per min (95% confidence interval -9.2 to 4.3) during isradipine treatment. Pulsatility index in maternal and fetal vessels was not affected by either of the two drugs. The birth weight and placental weight and neonatal outcome were similar and uneventful. The hypotensive effect was similar for methyldopa and isradipine. Except reduced maternal heart rate on methyldopa, fetal and uteroplacental hemodynamics were not altered during treatment of preeclampsia with methyldopa or isradipine.

Antihypertensive Agents↗

PubMed2006

Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial.

BACKGROUND: No effective therapeutic options for patients with unresectable imatinib-resistant gastrointestinal stromal tumour are available. We did a randomised, double-blind, placebo-controlled, multicentre, international trial to assess tolerability and anticancer efficacy of sunitinib, a multitargeted tyrosine kinase inhibitor, in patients with advanced gastrointestinal stromal tumour who were resistant to or intolerant of previous treatment with imatinib. METHODS: Blinded sunitinib or placebo was given orally once daily at a 50-mg starting dose in 6-week cycles with 4 weeks on and 2 weeks off treatment. The primary endpoint was time to tumour progression. Intention-to-treat, modified intention-to-treat, and per-protocol analyses were done. This study is registered at ClinicalTrials.gov, number NCT00075218. FINDINGS: 312 patients were randomised in a 2:1 ratio to receive sunitinib (n=207) or placebo (n=105); the trial was unblinded early when a planned interim analysis showed significantly longer time to tumour progression with sunitinib. Median time to tumour progression was 27.3 weeks (95% CI 16.0-32.1) in patients receiving sunitinib and 6.4 weeks (4.4-10.0) in those on placebo (hazard ratio 0.33; p<0.0001). Therapy was reasonably well tolerated; the most common treatment-related adverse events were fatigue, diarrhoea, skin discolouration, and nausea. INTERPRETATION: We noted significant clinical benefit, including disease control and superior survival, with sunitinib compared with placebo in patients with advanced gastrointestinal stromal tumour after failure and discontinuation of imatinab. Tolerability was acceptable.

Adult↗

PubMed2006

Clinical efficacy and cognitive side effects of bifrontal versus right unilateral electroconvulsive therapy (ECT): a short-term randomised controlled trial in pharmaco-resistant major depression.

BACKGROUND: In most studies right unilateral electroconvulsive therapy (ECT) has been shown to cause fewer cognitive side effects but less antidepressant efficacy compared with bi(fronto)temporal ECT at certain intensities. AIMS: To compare the short-term efficacy and side effects of right unilateral ECT and bifrontal ECT. METHODS: In a double-blind randomised controlled clinical trial, 92 patients diagnosed with pharmaco-resistant major depression received either six right unilateral ECT treatments (250% stimulus intensity of titrated threshold) or six bifrontal ECT (150% of threshold) treatments over a 3-week period. Concomitant psychotropic medications were continued during ECT treatments. The severity of depression and cognitive status was assessed prior to the first ECT and one day after the sixth ECT using the 21-item Hamilton Depression Rating Scale and the modified Mini Mental State Examination. RESULTS: Eight patients did not complete the course of the study due to minor side effects or withdrawal of consent. The mean Hamilton Depression score decreased from 27 to 17 points in both groups of 46 patients, resulting in 12 responders (primary endpoint defined as a decrease >50%) in each patient group (95% confidence interval for the odds ratio from 0.35 to 2.8). There was no reduction in the modified Mini Mental State score (mean score 86 of 100 points). CONCLUSIONS: Both bifrontal and right unilateral electrode placements in ECT were reasonably safe and moderately efficacious in reducing symptoms of pharmaco-resistant major depression.

Adult↗

PubMed2005

Zinc and vitamin A supplementation in Australian Indigenous children with acute diarrhoea: a randomised controlled trial.

OBJECTIVE: To evaluate the role of zinc and vitamin A supplementation in the recovery of Indigenous children hospitalised for acute diarrhoea. DESIGN: A randomised controlled 2 by 2 factorial trial of supplementation with zinc and vitamin A. SETTING AND PARTICIPANTS: Aboriginal children (aged < 11 years) hospitalised for acute diarrhoea at Alice Springs Hospital, Northern Territory, April 2001-July 2002. MAIN OUTCOME MEASURES: Duration of diarrhoeal illness; re-admission for diarrhoeal illness within 120 days. RESULTS: Our study involved 392 Aboriginal children with 436 episodes of diarrhoea. Supplementation with zinc, vitamin A, or combined zinc and vitamin A had no significant effect on duration of diarrhoea or rate of re-admission compared with placebo. Median diarrhoea duration after starting supplementation was 3.0 days for the vitamin A and zinc supplemented and placebo groups (P values 0.25 and 0.69, respectively). The number of re-admissions did not differ significantly between those receiving vitamin A or zinc and the relevant placebo groups (relative risk [95% CI], 1.2 [0.7-2.1] and 1.3 [0.8-2.1], respectively). CONCLUSION: Vitamin A and zinc supplementation may not be indicated for in-hospital management of acute diarrhoeal disease in Aboriginal children living in remote areas. This finding may not apply to children with malnutrition, for whom other studies suggest a benefit. Larger trials incorporating more comprehensive data on the vitamin A and zinc status as well as nutritional status of study populations might help to explain the different results in different populations.

Acute Disease↗

PubMed2006

Zinc and vitamin A supplementation in Indigenous Australian children hospitalised with lower respiratory tract infection: a randomised controlled trial.

OBJECTIVE: To evaluate the efficacy of supplementation with zinc and vitamin A in Indigenous children hospitalised with acute lower respiratory infection (ALRI). DESIGN: Randomised controlled, 2-by-2 factorial trial of supplementation with zinc and vitamin A. SETTING AND PARTICIPANTS: 187 Indigenous children aged < 11 years hospitalised with 215 ALRI episodes at Alice Springs Hospital (April 2001 to July 2002). INTERVENTIONS: Vitamin A was administered on Days 1 and 5 of admission at a dose of 50 000 IU (infants under 12 months), or 100 000 IU; and zinc sulfate was administered daily for 5 days at a daily dose of 20 mg (infants under 12 months) or 40 mg. MAIN OUTCOME MEASURE: Time to clinical recovery from fever and tachypnoea, duration of hospitalisation, and readmission for ALRI within 120 days. RESULTS: There was no clinical benefit of supplementation with vitamin A, zinc or the two combined, with no significant difference between zinc and no-zinc, vitamin A and no-vitamin A or zinc + vitamin A and placebo groups in time to resolution of fever or tachypnoea, or duration of hospitalisation. Instead, we found increased morbidity; children given zinc had increased risk of readmission for ALRI within 120 days (relative risk, 2.4; 95% CI, 1.003-6.1). CONCLUSION: This study does not support the use of vitamin A or zinc supplementation in the management of ALRI requiring hospitalisation in Indigenous children living in remote areas. Even in populations with high rates of ALRI and poor living conditions, vitamin A and zinc therapy may not be useful. The effect of supplementation may depend on the prevalence of deficiency of these micronutrients in the population.

Child↗

PubMed2001

Antibiotic prophylaxis to prevent post-abortal upper genital tract infection in women with bacterial vaginosis: randomised controlled trial.

OBJECTIVE: To determine the prevalence of bacterial vaginosis in women undergoing first trimester suction termination of pregnancy and to evaluate the efficacy of metronidazole in reducing the risk of post abortal pelvic infection in women with bacterial vaginosis. DESIGN: Randomised double-blind placebo-controlled trial. SETTING: Two teaching hospitals and one district general hospital. SAMPLE: Two hundred and seventy-three women with bacterial vaginosis undergoing termination of pregnancy. METHODS: Women with bacterial vaginosis, diagnosed using modified Spiegel's criteria, were individually randomised to receive either a 2 g metronidazole suppository or identical placebo per-operatively. Participants, doctors and investigators were blinded to treatment allocation. Participants were asked to complete a questionnaire about post-operative symptoms, visits to the general practitioner, antibiotic treatment, readmission to hospital, contraception and emotional response after one month. RESULTS: The prevalence of bacterial vaginosis was 29.3% (326/1,111). Intention-to-treat analysis showed that post-operative upper genital tract infection developed in 12/142 (8.5%) women allocated to metronidazole and 21/131 (16.0%) women randomised to placebo, a difference of 7.6% (95% confidence intervals -15.4 to +0.2%; relative risk 0.53. 0.27 to 1.03, P = 0.055). The effect of prophylaxis was similar when the analysis was restricted to women receiving the allocated treatment and with complete follow up. There was no difference in the risk of readmission to hospital and the frequencies of self reported symptoms in the two groups were similar. CONCLUSION: This randomised placebo-controlled trial among women with bacterial vaginosis provides weak evidence that metronidazole decreases the risk of upper genital tract infection after first trimester suction termination of pregnancy but a chance finding could not confidently be excluded. Large well-conducted randomised trials with long term outcome measures are now needed to determine the most effective antibiotic combinations and strategy for prevention of post-abortal pelvic infection.

Abortion, Induced↗

PubMed1995

Oral versus intravenous antibiotics for community acquired lower respiratory tract infection in a general hospital: open, randomised controlled trial.

OBJECTIVE: To see whether there is a difference in outcome between patients treated with oral and intravenous antibiotics for lower respiratory tract infection. DESIGN: Open controlled trial in patients admitted consecutively and randomised to treatment with either oral co-amoxiclav, intravenous followed by oral co-amoxiclav, or intravenous followed by oral cephalosporins. SETTING: Large general hospital in Dublin. PATIENTS: 541 patients admitted for lower respiratory tract infection during one year. Patients represented 87% of admissions with the diagnosis and excluded those who were immunocompromised and patients with severe life threatening infection. MAIN OUTCOME MEASURES: Cure, partial cure, extended antibiotic treatment, change of antibiotic, death, and cost and duration of hospital stay. RESULTS: There were no significant differences between the groups in clinical outcome or mortality (6%). However, patients randomised to oral co-amoxiclav had a significantly shorter hospital stay than the two groups given intravenous antibiotic (median 6 v 7 and 9 days respectively). In addition, oral antibiotics were cheaper, easier to administer, and if used routinely in the 800 or so patients admitted annually would lead to savings of around 176,000 pounds a year. CONCLUSIONS: Oral antibiotics in community acquired lower respiratory tract infection are at least as efficacious as intraveous therapy. Their use reduces labour and equipment costs and may lead to earlier discharge from hospital.

Administration, Oral↗

PubMed1999

A randomised control trial of surgical task performance in rigid bronchoscopy: foreign body extraction with optical versus non-optical forceps.

There are currently two types of forceps used for foreign body removal at rigid bronchoscopy, these can be classified as standard bronchoscopy forceps and optically guided grasping forceps. In order to evaluate them in the removal of foreign bodies from the tracheo-bronchial tree a randomised subject controlled trial was conducted. All 80 bronchoscopies were recorded and analysed by a single observer according to predetermined criteria for surgical error. The data was analysed using a t-test for paired groups. The results showed no significant differences between the two groups. We conclude that no clear advantages were found comparing the optically guided forceps with the standard bronchoscopy forceps and that further clinical evaluation will be difficult to initiate.

Animals↗

PubMed1998

Randomised controlled trial of paracetamol for heel prick pain in neonates.

AIM: To evaluate the effectiveness of paracetamol in decreasing the pain from heel prick. METHODS: A prospective randomised double blind placebo controlled trial was conducted of 75 term neonates undergoing heel prick. Sixty to 90 minutes before the procedure neonates received paracetamol orally in a dose of 20 mg/kg (group 1) or an equal volume of placebo (group 2). Heel prick was performed in a standardised manner. Pain assessments were made using per cent facial action (brow bulge, eye squeeze, and nasolabial fold (range 0-300%) and per cent of time spent crying (range 0-100%). RESULTS: Thirty eight neonates were enrolled in group 1 and 37 neonates in group 2. There were no significant differences in the demographic characteristics between groups. Mean gestational age was 39 (SD 1.4) vs 39.4 (SD 1.2) weeks, p = 0.86, mean birthweight 3.45 (SD 0.45) vs 3.44 (SD 0.42) kg; p = 0.31 for groups 1 and 2, respectively. Facial action pain scores did not differ between groups (143.5 (SD 54.2)% vs 131.1 (SD 59.6)%; p = 0.38). Cry scores also did not differ (29.4 (SD 19.9)% vs 26.8 (SD 20.2)%; p = 0.60). No adverse effects were observed. CONCLUSION: Paracetamol is ineffective for decreasing the pain from heel prick in term neonates.

Acetaminophen↗