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
  Purpose

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 Intervention
Fracture
Pain
Drug: Acetaminophen and Ibuprofen
Drug: Acetaminophen and Codeine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Ibuprofen vs. Codeine. Is One Better for Post-operative Pain Relief Following Reduction of Paediatric Forearm Fractures?

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605240

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

Locations
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:

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01605240     History of Changes
Other Study ID Numbers: H2012:092
Study First Received: May 22, 2012
Last Updated: July 24, 2013
Health Authority: Canada: Research Ethics Board

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

ClinicalTrials.gov processed this record on October 29, 2014