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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01605240
• Other study ID #: H2012:092
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2012
• Last updated: July 24, 2013
• Start date: July 2012
• Est. completion date: August 2014

Study information

• Verified date: July 2013
• Source: University of Manitoba
• Contact: Paul Jellicoe, MD
• Phone: 204-787-8948
• Is FDA regulated: No
• Health authority: Canada: Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone
• Pain
• Pain, Postoperative

Intervention

Drug:
• Acetaminophen and Ibuprofen
After their fracture is reduced, these patients will receive acetaminophen (15mg/kg) and ibuprofen (10mg/kg) at regular dosing intervals.
• Acetaminophen and Codeine
After their fracture is reduced, these patients will receive acetaminophen (15mg/kg) and codeine (1mg/kg) at regular dosing intervals.

Locations

Country	Name	City	State
Canada	Health Sciences Center	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Diary	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.	Two Weeks	Yes
Secondary	Patient Satisfaction	Parent satisfaction will be measured each day with the use of a Likert 0-5 scale.	2 weeks	No