Prospective Comparative Study of the Efficacy of Common Antipyretic Treatments in Febrile Children

NCT02294071 | Unknown Phase 4

• 1 other identifier: LHRI IRF
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Fever

Keywords

acetaminophen; ibuprofen

Outcome Measures

Primary Outcomes (1)

• temperature reduction from baseline

  change in temperature from baseline at time of drug administration and at five minute intervals afterward for a minimum of one hour, maximum 4 hours

  4 hours

Study Arms (3)

acetaminophen

EXPERIMENTAL

acetaminophen 15mg/kg (max 975mg)

Drug: Acetaminophen

ibuprofen

EXPERIMENTAL

ibuprofen 10mg/kg (max 600mg)

Drug: Ibuprofen

combination

EXPERIMENTAL

acetaminophen 15mg/kg (max 975mg) and ibuprofen 10mg/kg (max 600mg)

Drug: Ibuprofen; Drug: Acetaminophen

Interventions

Ibuprofen DRUG

oral liquid ibuprofen 10mg/kg (maximum 600 mg)

Also known as: Advil

combination; ibuprofen

Acetaminophen DRUG

oral liquid acetaminophen 15mg/kg (max 975mg)

Also known as: Tylenol

acetaminophen; combination

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• fever between 38 and 41 Celsius (inclusive) on presentation to ER
• assessment by treating physician that patient requires antipyretic treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Related Publications (16)

• 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.

  PMID: 21503807 BACKGROUND

• 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.

  PMID: 22373120 BACKGROUND

• 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.

  PMID: 21357332 BACKGROUND

• 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;2013(10):CD009572. doi: 10.1002/14651858.CD009572.pub2.

  PMID: 24174375 BACKGROUND

• D Leduc SWCPSCPC. Temperature measurement in pediatrics. Canadian Pediatric Society. 2013.

  BACKGROUND

• Mayoral CE, Marino RV, Rosenfeld W, Greensher J. Alternating antipyretics: is this an alternative? Pediatrics. 2000 May;105(5):1009-12. doi: 10.1542/peds.105.5.1009.

  PMID: 10790455 BACKGROUND

• 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.

  PMID: 24551584 BACKGROUND

• Allan GM, Ivers N, Shevchuk Y. Treatment of pediatric fever: Are acetaminophen and ibuprofen equivalent? Can Fam Physician. 2010 Aug;56(8):773. No abstract available.

  PMID: 20705883 BACKGROUND

• 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. doi: 10.1136/adc.2005.087874. Epub 2006 Feb 7.

  PMID: 16464962 BACKGROUND

• 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.

  PMID: 18765450 BACKGROUND

• 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.

  PMID: 18539869 BACKGROUND

• 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.

  PMID: 21353111 BACKGROUND

• 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. doi: 10.1023/a:1023225217108.

  PMID: 10205771 BACKGROUND

• Kauffman RE, Sawyer LA, Scheinbaum ML. Antipyretic efficacy of ibuprofen vs acetaminophen. Am J Dis Child. 1992 May;146(5):622-5. doi: 10.1001/archpedi.1992.02160170102024.

  PMID: 1621668 BACKGROUND

• 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.

  PMID: 23972576 BACKGROUND

• Troconiz IF, Armenteros S, Planelles MV, Benitez J, Calvo R, Dominguez R. Pharmacokinetic-Pharmacodynamic Modelling of the antipyretic effect of two oral formulations of ibuprofen. Clin Pharmacokinet. 2000 Jun;38(6):505-18. doi: 10.2165/00003088-200038060-00004.

  PMID: 10885587 BACKGROUND

MeSH Terms

Conditions

Fever

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Michael J Rieder, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Rieder, MD

CONTACT

(519) 685-8500; mrieder@uwo.ca

Lauren Faught, PhD

CONTACT

519-661-3221; lhanly2@uwo.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 19, 2014
• Study Start: December 1, 2014
• Primary Completion: November 1, 2015
• Last Updated: November 19, 2014

Record last verified: 2014-11