Ibuprofen Versus Codeine. Is One Better for Post-operative Pain Relief Following Reduction of Paediatric Forearm Fractures?

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ClinicalTrials.gov Identifier: NCT01605240

Recruitment Status : Unknown

Verified July 2013 by University of Manitoba.
Recruitment status was: Recruiting

First Posted : May 24, 2012

Last Update Posted : July 25, 2013

Sponsor:

Information provided by (Responsible Party):

University of Manitoba

Study Description

Brief Summary:

For simple fractures treated in the emergency department with cast immobilisation only, ibuprofen has been shown to be superior to, or a least or equivalent to codeine with less side effects. These and other studies have commented that their results may not be applicable to children who have fractures that require reduction. There is currently no literature on the management of postoperative pain following reduction of paediatric fractures. The investigators aim therefore is to investigate whether either of the two most commonly prescribed analgesics is superior to the other for postoperative pain management following closed reductions of paediatric forearm fractures. Also, if one agent has more side effects than the other.

Condition or disease	Intervention/treatment	Phase
Fracture Pain	Drug: Acetaminophen and Ibuprofen Drug: Acetaminophen and Codeine	Not Applicable

Detailed Description:

This will be a prospective randomised controlled trial with the null hypothesis that there is no difference between ibuprofen and codeine in terms of pain relief or side effects.

Following ethics approval (submitted and approved) by the University of Manitoba ethics board a study group of fifty patients (25 in each arm) will be recruited to participate in the study.All patients will complete informed consent following both a verbal and written explanation of the study. Following the closed reduction they will all receive regular acetaminophen; (dose 15mg/kg) and either ibuprofen (10mg/kg) or codeine (1mg/kg) depending upon the group they were randomised to. This will have to be single blinding as the codeine formulation used by the hospital is a clear red liquid (5mg/ml) and the ibuprofen a cloudy colourless liquid (20mg/ml). They will also be given a "rescue" medication to be taken if the caregivers feel that the pain relief is not sufficient 1 hour after the study medication. This rescue medication will be the alternative medication in the study.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Ibuprofen vs. Codeine. Is One Better for Post-operative Pain Relief Following Reduction of Paediatric Forearm Fractures?
Study Start Date :	July 2012
Estimated Primary Completion Date :	December 2013
Estimated Study Completion Date :	August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Children's Health Fractures

Drug Information available for: Codeine Acetaminophen Ibuprofen Ibuprofen sodium Ibuprofen lysine Midol

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Acetaminophen and Codeine After their fracture is reduced, these patients will receive acetaminophen (15mg/kg) and codeine (1mg/kg) at regular dosing intervals.	Drug: Acetaminophen and Codeine After their fracture is reduced, these patients will receive acetaminophen (15mg/kg) and codeine (1mg/kg) at regular dosing intervals.
Active Comparator: Acetaminophen and Ibuprofen Following reduction of their fracture, these patients will receive acetaminophen (15mg/ml) and ibuprofen (10mg/ml) at regular dosing intervals.	Drug: Acetaminophen and Ibuprofen After their fracture is reduced, these patients will receive acetaminophen (15mg/kg) and ibuprofen (10mg/kg) at regular dosing intervals. Other Name: Ibuprofen (Advil)

Outcome Measures

Primary Outcome Measures :

Pain Diary [ Time Frame: Two Weeks ]
Caregivers, or the children if old enough, will be asked to keep a pain diary. This will consist of the times the analgesia was taken and a pain score at awakening, at bedtime and before and 1 hour after each dose of medication.

Caregivers/children will also be asked to include any side effects noted to medication and whether play, school, sleep, and eating are affected by pain each day. Caregivers will record whether the function was increased, decreased, or unchanged.

Secondary Outcome Measures :

Patient Satisfaction [ Time Frame: 2 weeks ]
Parent satisfaction will be measured each day with the use of a Likert 0-5 scale.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	3 Years to 16 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All paediatric patients presenting to the section of paediatric orthopaedics requiring a closed reduction of a forearm fraction under either sedation or general anaesthetic.
Patients who are able to return to follow up.

Exclusion Criteria:

Any children with a history of gastrointestinal bleeding or ulceration, a bleeding disorder, a history of a low platelet count, a history of kidney disease, an uncontrolled chronic disease, or regular use of or allergy to acetaminophen, ibuprofen, or codeine.
Children are also ineligible if they or their parents are unable to understand the consent process.
Any child requiring anything other than a cast to supplement the stability of the fracture or an open reduction and internal fixation of the fracture.

Open fractures.

Contacts and Locations

Information from the National Library of Medicine

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): NCT01605240

Contacts

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Contact: Paul Jellicoe, MD	204-787-8948
Contact: James R McCammon, MD	204-779-8673	j_mccammon@hotmail.com

Locations

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Canada, Manitoba
Health Sciences Center	Recruiting
Winnipeg, Manitoba, Canada
Contact: Paul Jellicoe, MD Ph: 204 787 8948 pjellicoe@exchange.hsc.mb.ca
Contact: James R McCammon, MD 204-779-8673 j_mccammon@hotmail.com
Principal Investigator: Paul Jellicoe, MD
Sub-Investigator: James R McCammon, MD, BSC(med), BMR(PT)

Sponsors and Collaborators

University of Manitoba

More Information

Publications:

Drendel AL, Lyon R, Bergholte J, Kim MK. Outpatient pediatric pain management practices for fractures. Pediatr Emerg Care. 2006 Feb;22(2):94-9.

Drendel AL, Gorelick MH, Weisman SJ, Lyon R, Brousseau DC, Kim MK. A randomized clinical trial of ibuprofen versus acetaminophen with codeine for acute pediatric arm fracture pain. Ann Emerg Med. 2009 Oct;54(4):553-60. doi: 10.1016/j.annemergmed.2009.06.005. Epub 2009 Aug 19.

Koller DM, Myers AB, Lorenz D, Godambe SA. Effectiveness of oxycodone, ibuprofen, or the combination in the initial management of orthopedic injury-related pain in children. Pediatr Emerg Care. 2007 Sep;23(9):627-33.

Oakley EA, Ooi KS, Barnett PL. A randomized controlled trial of 2 methods of immobilizing torus fractures of the distal forearm. Pediatr Emerg Care. 2008 Feb;24(2):65-70. doi: 10.1097/PEC.0b013e318163db13.

Plint AC, Perry JJ, Correll R, Gaboury I, Lawton L. A randomized, controlled trial of removable splinting versus casting for wrist buckle fractures in children. Pediatrics. 2006 Mar;117(3):691-7.

Heidrich G, Slavic-Svircev V, Kaiko RF. Efficacy and quality of ibuprofen and acetaminophen plus codeine analgesia. Pain. 1985 Aug;22(4):385-97.

Clark E, Plint AC, Correll R, Gaboury I, Passi B. A randomized, controlled trial of acetaminophen, ibuprofen, and codeine for acute pain relief in children with musculoskeletal trauma. Pediatrics. 2007 Mar;119(3):460-7. Erratum in: Pediatrics. 2007 Jun;119(6):1271.

Bieri D, Reeve RA, Champion GD, Addicoat L, Ziegler JB. The Faces Pain Scale for the self-assessment of the severity of pain experienced by children: development, initial validation, and preliminary investigation for ratio scale properties. Pain. 1990 May;41(2):139-50.

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Responsible Party:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT01605240
Other Study ID Numbers:	H2012:092
First Posted:	May 24, 2012 Key Record Dates
Last Update Posted:	July 25, 2013
Last Verified:	July 2013

Keywords provided by University of Manitoba:


Fracture pain Fracture reduction Analgesia Acetaminophen	Ibuprofen Codeine Pediatric Fracture Pain Analgesia in Pediatric population

Additional relevant MeSH terms:

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Pain, Postoperative Fractures, Bone Wounds and Injuries Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Signs and Symptoms Acetaminophen Ibuprofen Codeine Analgesics, Non-Narcotic Analgesics Sensory System Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Narcotics Central Nervous System Depressants Antitussive Agents Respiratory System Agents

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