Prospective Comparative Study of the Efficacy of Common Antipyretic Treatments in Febrile Children
Information source: Lawson Health Research Institute
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fever
Intervention: Ibuprofen (Drug); Acetaminophen (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Lawson Health Research Institute Official(s) and/or principal investigator(s): Michael J Rieder, MD, Principal Investigator, Affiliation: University of Western Ontario, Canada
Overall contact: Michael J Rieder, MD, Phone: (519) 685-8500, Ext: 58293, Email: mrieder@uwo.ca
Summary
This study will examine in detail the immediate effects of three common treatments given to
children with fevers to lower their temperature. Each child will be given either ibuprofen,
acetaminophen, or a combination, and their temperature monitored at five-minute intervals.
The temperature-lowering effects of each treatment will be compared to evaluate which is
most effective.
Clinical Details
Official title: Prospective Comparative Study of the Efficacy of Common Antipyretic Treatments in Febrile Children
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: temperature reduction from baseline
Detailed description:
There is no substantial evidence that a fever lower than 41°C is harmful to the welfare of
an otherwise healthy child, although they can be dangerous to children already in critical
condition [1,2]. However, fevers in healthy children commonly cause anxiety in parents and
caregivers, so parents and physicians often give antipyretic medications to lower the fever
[3,4]. Ibuprofen and acetaminophen are two of the most commonly used medications in
children. Most major pediatric medical associations agree about appropriate dosages for
children, but give no clear guidelines on whether ibuprofen or acetaminophen should be used
[3,5]. Physicians commonly make the decision between the two based on their personal
opinions of the efficacy and safety of the medications, or based on habit [6]. Survey data
shows that more than half of physicians use combinations of both acetaminophen and ibuprofen
to treat fever, either simultaneously or on an alternating schedule, with a variety of
dosing patterns [6]. A majority of physicians believed there were established guidelines
supporting this use, but in fact there are not [6].
Combining the two medications is widely theorized to improve effectiveness, but clinical
trials comparing combination treatments to ibuprofen and/or acetaminophen alone have shown
inconsistent results [4,7-12]. Several pharmacodynamic studies have shown that ibuprofen and
acetaminophen both produce their largest effects on temperature within the first hour
following dosage [9,10,13-16]. Despite this, only one study has been performed examining the
change in temperature at intervals shorter than 30 minutes, and that study used substandard
monitoring methods [10].
This study will use gold-standard monitoring methods to take temperatures every five minutes
through the first one to four hours of treatment. Understanding the pattern of temperature
change in the acute stages after dosing will help settle the debate about the optimal
medication choice for treating childrens' fevers.
Eligibility
Minimum age: 3 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- fever between 38 and 41 Celsius (inclusive) on presentation to ER
- assessment by treating physician that patient requires antipyretic treatment
Exclusion Criteria:
- known allergy or hypersensitivity to either study medication
- received any antipyretic medication in past eight hours
- patient requires admission to hospital
- co-morbidities indicating increased risk of complication
- assessment by treating physician that patient is medically unsuitable for the study
Locations and Contacts
Michael J Rieder, MD, Phone: (519) 685-8500, Ext: 58293, Email: mrieder@uwo.ca Additional Information
Related publications: Mullins ME, Empey M, Jaramillo D, Sosa S, Human T, Diringer MN. A prospective randomized study to evaluate the antipyretic effect of the combination of acetaminophen and ibuprofen in neurological ICU patients. Neurocrit Care. 2011 Dec;15(3):375-8. doi: 10.1007/s12028-011-9533-8. Lee BH, Inui D, Suh GY, Kim JY, Kwon JY, Park J, Tada K, Tanaka K, Ietsugu K, Uehara K, Dote K, Tajimi K, Morita K, Matsuo K, Hoshino K, Hosokawa K, Lee KH, Lee KM, Takatori M, Nishimura M, Sanui M, Ito M, Egi M, Honda N, Okayama N, Shime N, Tsuruta R, Nogami S, Yoon SH, Fujitani S, Koh SO, Takeda S, Saito S, Hong SJ, Yamamoto T, Yokoyama T, Yamaguchi T, Nishiyama T, Igarashi T, Kakihana Y, Koh Y; Fever and Antipyretic in Critically ill patients Evaluation (FACE) Study Group. Association of body temperature and antipyretic treatments with mortality of critically ill patients with and without sepsis: multi-centered prospective observational study. Crit Care. 2012 Feb 28;16(1):R33. doi: 10.1186/cc11211. Erratum in: Crit Care. 2012;16(1):450. Section on Clinical Pharmacology and Therapeutics; Committee on Drugs, Sullivan JE, Farrar HC. Fever and antipyretic use in children. Pediatrics. 2011 Mar;127(3):580-7. doi: 10.1542/peds.2010-3852. Epub 2011 Feb 28. Review. Wong T, Stang AS, Ganshorn H, Hartling L, Maconochie IK, Thomsen AM, Johnson DW. Combined and alternating paracetamol and ibuprofen therapy for febrile children. Cochrane Database Syst Rev. 2013 Oct 30;10:CD009572. doi: 10.1002/14651858.CD009572.pub2. Review. D Leduc SWCPSCPC. Temperature measurement in pediatrics. Canadian Pediatric Society. 2013. Mayoral CE, Marino RV, Rosenfeld W, Greensher J. Alternating antipyretics: is this an alternative? Pediatrics. 2000 May;105(5):1009-12. Vyas FI, Rana DA, Patel PM, Patel VJ, Bhavsar RH. Randomized comparative trial of efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children. Perspect Clin Res. 2014 Jan;5(1):25-31. doi: 10.4103/2229-3485.124567. Allan GM, Ivers N, Shevchuk Y. Treatment of pediatric fever: Are acetaminophen and ibuprofen equivalent? Can Fam Physician. 2010 Aug;56(8):773. Erlewyn-Lajeunesse MD, Coppens K, Hunt LP, Chinnick PJ, Davies P, Higginson IM, Benger JR. Randomised controlled trial of combined paracetamol and ibuprofen for fever. Arch Dis Child. 2006 May;91(5):414-6. Epub 2006 Feb 7. Hay AD, Costelloe C, Redmond NM, Montgomery AA, Fletcher M, Hollinghurst S, Peters TJ. Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial. BMJ. 2008 Sep 2;337:a1302. doi: 10.1136/bmj.a1302. Erratum in: BMJ. 2009;339:b3295. Kramer LC, Richards PA, Thompson AM, Harper DP, Fairchok MP. Alternating antipyretics: antipyretic efficacy of acetaminophen versus acetaminophen alternated with ibuprofen in children. Clin Pediatr (Phila). 2008 Nov;47(9):907-11. doi: 10.1177/0009922808319967. Epub 2008 Jun 6. Paul IM, Sturgis SA, Yang C, Engle L, Watts H, Berlin CM Jr. Efficacy of standard doses of Ibuprofen alone, alternating, and combined with acetaminophen for the treatment of febrile children. Clin Ther. 2010 Dec;32(14):2433-40. doi: 10.1016/j.clinthera.2011.01.006. Brown RD, Kearns GL, Wilson JT. Integrated pharmacokinetic-pharmacodynamic model for acetaminophen, ibuprofen, and placebo antipyresis in children. J Pharmacokinet Biopharm. 1998 Oct;26(5):559-79. Kauffman RE, Sawyer LA, Scheinbaum ML. Antipyretic efficacy of ibuprofen vs acetaminophen. Am J Dis Child. 1992 May;146(5):622-5. Temple AR, Temple BR, Kuffner EK. Dosing and antipyretic efficacy of oral acetaminophen in children. Clin Ther. 2013 Sep;35(9):1361-75.e1-45. doi: 10.1016/j.clinthera.2013.06.022. Epub 2013 Aug 23. Review. TrocĂłniz IF, Armenteros S, Planelles MV, BenĂtez J, Calvo R, DomĂnguez R. Pharmacokinetic-Pharmacodynamic Modelling of the antipyretic effect of two oral formulations of ibuprofen. Clin Pharmacokinet. 2000 Jun;38(6):505-18.
Starting date: December 2014
Last updated: November 17, 2014
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