Dataset Information

Alternating ibuprofen and acetaminophen in the treatment of febrile children: a pilot study [ISRCTN30487061].

ABSTRACT:

Background

Alternating ibuprofen and acetaminophen for the treatment of febrile children is a prevalent practice among physicians and parents, despite the lack of evidence on effectiveness or safety. This randomized, double-blind and placebo-controlled clinical trial aims at comparing the antipyretic effectiveness and safety of a single administration of alternating ibuprofen and acetaminophen doses to that of ibuprofen mono-therapy in febrile children.

Methods

Seventy febrile children were randomly allocated to receive either a single oral dose of 10 mg/kg ibuprofen and 15 mg/kg oral acetaminophen after 4 hours, or a similar dose of ibuprofen and placebo at 4 hours. Rectal temperature was measured at baseline, 4, 5, 6, 7 and 8 hours later. Endpoints included proportions of afebrile children at 6, 7 and 8 hours, maximum decline in temperature, time to recurrence of fever, and change in temperature from baseline at each time point. Intent-to-treat analysis was planned with statistical significance set at P < 0.05.

Results

A higher proportion of subjects in the intervention group (83.3%) became afebrile at 6 hours than in the control group (57.6%); P = 0.018. This difference was accentuated at 7 and 8 hours (P < 0.001) with a significantly longer time to recurrence of fever in the intervention group (mean +/- SD of 7.4 +/- 1.3 versus 5.7 +/- 2.2 hours), P < 0.001. Odds ratios (95%CI) for defervescence were 5.6 (1.3; 23.8), 19.5 (3.5; 108.9) and 15.3 (3.4; 68.3) at 6, 7 and 8 hours respectively. Two-way ANOVA with repeated measures over time revealed a significantly larger decline in temperature in the intervention group at times 7 (P = 0.026) and 8 (P = 0.002) hours.

Conclusion

A single dose of alternating ibuprofen and acetaminophen appears to be a superior antipyretic regimen than ibuprofen mono-therapy. Further studies are needed to confirm these findings.

SUBMITTER: Nabulsi MM

PROVIDER: S-EPMC1421419 | biostudies-literature | 2006 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Alternating ibuprofen and acetaminophen in the treatment of febrile children: a pilot study [ISRCTN30487061].

Nabulsi Mona M MM Tamim Hala H Mahfoud Ziyad Z Itani Mohammad M Sabra Ramzi R Chamseddine Fadi F Mikati Mohammad M

BMC medicine 20060304

<h4>Background</h4>Alternating ibuprofen and acetaminophen for the treatment of febrile children is a prevalent practice among physicians and parents, despite the lack of evidence on effectiveness or safety. This randomized, double-blind and placebo-controlled clinical trial aims at comparing the antipyretic effectiveness and safety of a single administration of alternating ibuprofen and acetaminophen doses to that of ibuprofen mono-therapy in febrile children.<h4>Methods</h4>Seventy febrile chi ...[more]

PMID: 16515705

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Project description:Background: Ibuprofen and paracetamol are the only antipyretics recommended in febrile children. According to international guidelines the choice of the drug should rely on the child's individual characteristics, while a controversial issue regards the combined or alternate use of the two drugs. Objective: To compare the efficacy and safety of combined or alternating use of ibuprofen and paracetamol in children. Methods: A systematic review of literature was performed on Medline and Embase databases. The included studies were randomized controlled trials analyzing the efficacy of combined or alternating therapy with antipyretics in febrile children vs. monotherapy. A meta-analysis was performed to measure the effect of treatment on child's temperature and discomfort. Adverse effects were analyzed as secondary outcome. Results: Nine studies were included, involving 2,026 children. Mean temperature was lower in the combined therapy group at 1 h (mean difference: -0.29°C; 95%CI: -0.45 to -0.13) after the initial administration of therapy. No statistical difference was found in mean temperature at 4 and 6 h from baseline. A significant difference was found in the proportion of children reaching apyrexia at 4 and 6 h with the combined treatment (RR: 0.18, 95%CI: 0.06 to 0.53, and 0.10, 95%CI: 0.01-0.71, respectively) and at 6 h with alternating treatment (RR: 0.30, 95% CI: 0.15-0.57), compared to children treated with monotherapy. The child's discomfort score was slightly lower with alternating therapy vs. monotherapy. The pooled mean difference in the number of medication doses per child used during the first 24 h was not significantly different among groups. Discussion: Combined or alternating therapy resulted more effective than monotherapy in reducing body temperature. However, the benefit appeared modest and probably not clinically relevant. The effect on child discomfort and number of doses of medication was modest as well. According to our findings, evidences are not robust enough to encourage combined or alternating paracetamol and ibuprofen instead of monotherapy to treat febrile children, reinforcing the current recommendation of most of the international guidelines.

Project description:BACKGROUND:Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking. METHODS:In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial. RESULTS:Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P=0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P=0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P=0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P=0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P=0.94), or adverse events. CONCLUSIONS:Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen. (Funded by the National Institutes of Health; AVICA ClinicalTrials.gov number, NCT01606319.).

Project description:ImportanceAcetaminophen (paracetamol) and ibuprofen are the most widely prescribed and available over-the-counter medications for management of fever and pain in children. Despite the common use of these medications, treatment recommendations for young children remain divergent.ObjectiveTo compare acetaminophen with ibuprofen for the short-term treatment of fever or pain in children younger than 2 years.Data sourcesSystematic search of the databases MEDLINE, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials and the trial registers ClinicalTrials.gov and the Australian New Zealand Clinical Trials Registry from inception to March 2019, with no language limits.Study selectionStudies of any design that included children younger than 2 years and directly compared acetaminophen with ibuprofen, reporting antipyretic, analgesic, and/or safety outcomes were considered. There were no limits on length of follow-up.Data extraction and synthesisFollowing the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline, 2 authors independently extracted data and assessed quality. Data were pooled using a fixed-effects method if I2 was less than 50% and using a random-effects method if I2 was 50% or greater.Main outcomes and measuresThe primary outcomes were fever or pain within 4 hours of treatment onset. Safety outcomes included serious adverse events, kidney impairment, gastrointestinal bleeding, hepatotoxicity, severe soft tissue infection, empyema, and asthma and/or wheeze.ResultsOverall, 19 studies (11 randomized; 8 nonrandomized) of 241 138 participants from 7 countries and various health care settings (hospital-based and community-based) were included. Compared with acetaminophen, ibuprofen resulted in reduced temperature at less than 4 hours (4 studies with 435 participants; standardized mean difference [SMD], 0.38; 95% CI, 0.08-0.67; P = .01; I2 = 49%; moderate quality evidence) and at 4 to 24 hours (5 studies with 879 participants; SMD, 0.24; 95% CI, 0.03-0.45; P = .03; I2 = 57%; moderate-quality evidence) and less pain at 4 to 24 hours (2 studies with 535 participants; SMD, 0.20; 95% CI, 0.03-0.37; P = .02; I2 = 25%; moderate-quality evidence). Adverse events were uncommon. Acetaminophen and ibuprofen appeared to have similar serious adverse event profiles (7 studies with 27 932 participants; ibuprofen vs aceteminophen: odds ratio, 1.08; 95% CI, 0.87-1.33; P = .50, I2 = 0%; moderate-quality evidence).Conclusions and relevanceIn this study, use of ibuprofen vs acetaminophen for the treatment of fever or pain in children younger than 2 years was associated with reduced temperature and less pain within the first 24 hours of treatment, with equivalent safety.

Dataset Information

Alternating ibuprofen and acetaminophen in the treatment of febrile children: a pilot study [ISRCTN30487061].

Background

Methods

Results

Conclusion

Publications

Alternating ibuprofen and acetaminophen in the treatment of febrile children: a pilot study [ISRCTN30487061].

Similar Datasets

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