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

Tracking Information
First Submitted Date ICMJE	May 22, 2012
First Posted Date ICMJE	May 24, 2012
Last Update Posted Date	July 25, 2013
Study Start Date ICMJE	July 2012
Estimated Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 23, 2012)	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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01605240 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 23, 2012)	Patient Satisfaction [ Time Frame: 2 weeks ]; Parent satisfaction will be measured each day with the use of a Likert 0-5 scale.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Ibuprofen Versus Codeine. Is One Better for Post-operative Pain Relief Following Reduction of Paediatric Forearm Fractures?
Official Title ICMJE	Ibuprofen vs. Codeine. Is One Better for Post-operative Pain Relief Following Reduction of Paediatric Forearm Fractures?
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.
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition ICMJE	Fracture; Pain
Intervention ICMJE	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); Drug: Acetaminophen and Codeine After their fracture is reduced, these patients will receive acetaminophen (15mg/kg) and codeine (1mg/kg) at regular dosing intervals.
Study Arms	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. Intervention: Drug: Acetaminophen and Codeine; 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. Intervention: Drug: Acetaminophen and Ibuprofen
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: May 23, 2012)	50
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	August 2014
Estimated Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	3 Years to 16 Years (Child)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01605240
Other Study ID Numbers ICMJE	H2012:092
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University of Manitoba
Study Sponsor ICMJE	University of Manitoba
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	University of Manitoba
Verification Date	July 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP