Recruiting

Ibuprofen vs. Codeine

Sponsor:

University of Manitoba

Code:

NCT01605240

Conditions

Fracture

Pain

Eligibility Criteria

Sex: All

Age: 3 - 16

Healthy Volunteers: Not accepted

Interventions

Acetaminophen and Ibuprofen

Acetaminophen and Codeine

Study Details

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.

Conditions

Fracture

Pain

Study ID

NCT01605240

Start date

Jul, 2012

Status verified date

Jul, 2013

Completion date

Aug, 2014

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 16

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

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.

Primary outcome measure

  • Pain Diary [ Time Frame: Two Weeks ]

Central Contacts and Locations

Central contacts

Paul Jellicoe, MD

204-787-8948

James R McCammon, MD

204-779-8673j_mccammon@hotmail.com

Locations

Health Sciences Center

Recruiting

Winnipeg, Manitoba, Canada

Contacts

Paul Jellicoe, MD

Ph: 204 787 8948pjellicoe@exchange.hsc.mb.ca

James R McCammon, MD

204-779-8673j_mccammon@hotmail.com

Principal Investigator:

Paul Jellicoe, MD

More Information

Sponsor

University of Manitoba

Last update posted

Jul 25, 2013

Last verified

Jul, 2013

Keywords

  • Fracture pain
  • Fracture reduction
  • Analgesia
  • Acetaminophen
  • Ibuprofen
  • Codeine
  • Pediatric
  • Fracture Pain Analgesia in Pediatric population

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2013-07-25.