Prospective Comparative Study of the Efficacy of Common Antipyretic Treatments in Febrile Children
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| ClinicalTrials.gov Identifier: NCT02294071 |
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Recruitment Status : Unknown
Verified November 2014 by Michael Rieder, Lawson Health Research Institute.
Recruitment status was: Not yet recruiting
First Posted : November 19, 2014
Last Update Posted : November 19, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fever | Drug: Ibuprofen Drug: Acetaminophen | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Prospective Comparative Study of the Efficacy of Common Antipyretic Treatments in Febrile Children |
| Study Start Date : | December 2014 |
| Estimated Primary Completion Date : | November 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: acetaminophen
acetaminophen 15mg/kg (max 975mg)
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Drug: Acetaminophen
oral liquid acetaminophen 15mg/kg (max 975mg)
Other Name: Tylenol |
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Experimental: ibuprofen
ibuprofen 10mg/kg (max 600mg)
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Drug: Ibuprofen
oral liquid ibuprofen 10mg/kg (maximum 600 mg)
Other Name: Advil |
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Experimental: combination
acetaminophen 15mg/kg (max 975mg) and ibuprofen 10mg/kg (max 600mg)
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Drug: Ibuprofen
oral liquid ibuprofen 10mg/kg (maximum 600 mg)
Other Name: Advil Drug: Acetaminophen oral liquid acetaminophen 15mg/kg (max 975mg)
Other Name: Tylenol |
- temperature reduction from baseline [ Time Frame: 4 hours ]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
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| Ages Eligible for Study: | 3 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294071
| Contact: Michael J Rieder, MD | (519) 685-8500 ext 58293 | mrieder@uwo.ca | |
| Contact: Lauren Faught, PhD | 519-661-3221 | lhanly2@uwo.ca |
| Principal Investigator: | Michael J Rieder, MD | University of Western Ontario, Canada |
Publications:
| Responsible Party: | Michael Rieder, Principal Investigator, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT02294071 |
| Other Study ID Numbers: |
LHRI IRF |
| First Posted: | November 19, 2014 Key Record Dates |
| Last Update Posted: | November 19, 2014 |
| Last Verified: | November 2014 |
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acetaminophen ibuprofen |
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Fever Body Temperature Changes Signs and Symptoms Acetaminophen Ibuprofen Antipyretics Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |