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Alternating ibuprofen and acetaminophen in the treatment of febrile children: a pilot study [ISRCTN30487061].
BMC Med. 2006 Mar 04; 4:4.BM

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.

Authors+Show Affiliations

Department of Pediatrics, American University of Beirut Medical Center, Beirut, Lebanon. mn04@aub.edu.lbNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16515705

Citation

Nabulsi, Mona M., et al. "Alternating Ibuprofen and Acetaminophen in the Treatment of Febrile Children: a Pilot Study [ISRCTN30487061]." BMC Medicine, vol. 4, 2006, p. 4.
Nabulsi MM, Tamim H, Mahfoud Z, et al. Alternating ibuprofen and acetaminophen in the treatment of febrile children: a pilot study [ISRCTN30487061]. BMC Med. 2006;4:4.
Nabulsi, M. M., Tamim, H., Mahfoud, Z., Itani, M., Sabra, R., Chamseddine, F., & Mikati, M. (2006). Alternating ibuprofen and acetaminophen in the treatment of febrile children: a pilot study [ISRCTN30487061]. BMC Medicine, 4, 4.
Nabulsi MM, et al. Alternating Ibuprofen and Acetaminophen in the Treatment of Febrile Children: a Pilot Study [ISRCTN30487061]. BMC Med. 2006 Mar 4;4:4. PubMed PMID: 16515705.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Alternating ibuprofen and acetaminophen in the treatment of febrile children: a pilot study [ISRCTN30487061]. AU - Nabulsi,Mona M, AU - Tamim,Hala, AU - Mahfoud,Ziyad, AU - Itani,Mohammad, AU - Sabra,Ramzi, AU - Chamseddine,Fadi, AU - Mikati,Mohammad, Y1 - 2006/03/04/ PY - 2005/12/11/received PY - 2006/03/04/accepted PY - 2006/3/7/pubmed PY - 2006/4/19/medline PY - 2006/3/7/entrez SP - 4 EP - 4 JF - BMC medicine JO - BMC Med VL - 4 N2 - 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. SN - 1741-7015 UR - https://www.unboundmedicine.com/medline/citation/16515705/Alternating_ibuprofen_and_acetaminophen_in_the_treatment_of_febrile_children:_a_pilot_study_[ISRCTN30487061]_ L2 - https://bmcmedicine.biomedcentral.com/articles/10.1186/1741-7015-4-4 DB - PRIME DP - Unbound Medicine ER -