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

NCT01605240 | Unknown DMC

• 1 other identifier: H2012:092
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Patient Satisfaction

  2 weeks

Study Arms (2)

Acetaminophen and Codeine

ACTIVE COMPARATOR

After their fracture is reduced, these patients will receive acetaminophen (15mg/kg) and codeine (1mg/kg) at regular dosing intervals.

Drug: Acetaminophen and Codeine

Acetaminophen and Ibuprofen

ACTIVE COMPARATOR

Following reduction of their fracture, these patients will receive acetaminophen (15mg/ml) and ibuprofen (10mg/ml) at regular dosing intervals.

Drug: Acetaminophen and Ibuprofen

Interventions

Acetaminophen and Ibuprofen DRUG

After their fracture is reduced, these patients will receive acetaminophen (15mg/kg) and ibuprofen (10mg/kg) at regular dosing intervals.

Also known as: Ibuprofen (Advil)

Acetaminophen and Ibuprofen

Acetaminophen and Codeine DRUG

After their fracture is reduced, these patients will receive acetaminophen (15mg/kg) and codeine (1mg/kg) at regular dosing intervals.

Acetaminophen and Codeine

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Center

Winnipeg, Manitoba, Canada

RECRUITING

Related Publications (8)

• Drendel AL, Lyon R, Bergholte J, Kim MK. Outpatient pediatric pain management practices for fractures. Pediatr Emerg Care. 2006 Feb;22(2):94-9. doi: 10.1097/01.pec.0000199564.64264.f4.

  PMID: 16481924 BACKGROUND

• 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.

  PMID: 19692147 BACKGROUND

• 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. doi: 10.1097/PEC.0b013e31814a6a39.

  PMID: 17876251 BACKGROUND

• 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.

  PMID: 18277840 BACKGROUND

• 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. doi: 10.1542/peds.2005-0801.

  PMID: 16510648 BACKGROUND

• Heidrich G, Slavic-Svircev V, Kaiko RF. Efficacy and quality of ibuprofen and acetaminophen plus codeine analgesia. Pain. 1985 Aug;22(4):385-397. doi: 10.1016/0304-3959(85)90044-2.

  PMID: 4047707 BACKGROUND

• 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. doi: 10.1542/peds.2006-1347.

  PMID: 17332198 BACKGROUND

• Bieri D, Reeve RA, Champion DG, 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):139-150. doi: 10.1016/0304-3959(90)90018-9.

  PMID: 2367140 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone; Pain; Agnosia

Interventions

Acetaminophen; Ibuprofen; acetaminophen, codeine drug combination

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Central Study Contacts

Paul Jellicoe, MD

CONTACT

204-787-8948

James R McCammon, MD

CONTACT

204-779-8673; j_mccammon@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: May 24, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: August 1, 2014
• Last Updated: July 25, 2013

Record last verified: 2013-07

Locations

CA (1)