Ibuprofen Versus Codeine. Is One Better for Post-operative Pain Relief Following Reduction of Paediatric Forearm Fractures?
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fracture Pain | Drug: Acetaminophen and Ibuprofen Drug: Acetaminophen and Codeine | Not Applicable |
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 : | 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 |
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)
|
- 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.
- Patient Satisfaction [ Time Frame: 2 weeks ]Parent satisfaction will be measured each day with the use of a Likert 0-5 scale.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 3 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Paul Jellicoe, MD | 204-787-8948 | ||
Contact: James R McCammon, MD | 204-779-8673 | j_mccammon@hotmail.com |
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) |
Publications:
Responsible Party: | University of Manitoba |
ClinicalTrials.gov Identifier: | NCT01605240 History of Changes |
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:
Fractures, Bone Pain, Postoperative Wounds and Injuries Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes 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 |