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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01605240
First received: May 22, 2012
Last updated: July 24, 2013
Last verified: July 2013

May 22, 2012
July 24, 2013
July 2012
December 2013   (final data collection date for primary outcome measure)
Pain Diary [ Time Frame: Two Weeks ] [ Designated as safety issue: Yes ]

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.

Same as current
Complete list of historical versions of study NCT01605240 on ClinicalTrials.gov Archive Site
Patient Satisfaction [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Parent satisfaction will be measured each day with the use of a Likert 0-5 scale.
Same as current
Not Provided
Not Provided
 
Ibuprofen Versus Codeine. Is One Better for Post-operative Pain Relief Following Reduction of Paediatric Forearm Fractures?
Ibuprofen vs. Codeine. Is One Better for Post-operative Pain Relief Following Reduction of Paediatric Forearm Fractures?

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Fracture
  • Pain
  • 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.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
August 2014
December 2013   (final data collection date for primary outcome measure)

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.

Both
3 Years to 16 Years
No
Contact: Paul Jellicoe, MD 204-787-8948
Contact: James R McCammon, MD 204-779-8673 j_mccammon@hotmail.com
Canada
 
NCT01605240
H2012:092
Yes
University of Manitoba
University of Manitoba
Not Provided
Not Provided
University of Manitoba
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP