Oral Morphine Versus Ibuprofen

Sponsor

Naveen Poonai (Other)

Overall Status

Completed

CT.gov ID

NCT01690780

Collaborator

(none)

183

Enrollment

Location

Arms

Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for the first 24 hours following discharge from the emergency department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in greater pain relief than ibuprofen.

Condition or Disease	Intervention/Treatment	Phase
Upper Extremity Fractures Analgesia Post Fracture	Drug: Oral morphine Drug: Ibuprofen	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

183 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Oral Morphine Versus Ibuprofen for Post-fracture Pain Management in Children: a Randomized Controlled Study

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ibuprofen	Drug: Ibuprofen Ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) for 24 hours following discharge from the emergency department
Experimental: Oral morphine	Drug: Oral morphine oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours

Arm

Intervention/Treatment

Active Comparator: Ibuprofen

Drug: Ibuprofen

Ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) for 24 hours following discharge from the emergency department

Experimental: Oral morphine

Drug: Oral morphine

oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours

Outcome Measures

Primary Outcome Measures

Faces Pain scale - revised [30 minutes post intervention compared to baseline]
The primary outcome variable is the pre-post intervention difference in pain scores as measured by self-reported Faces Pain Scale - Revised (FPS-R) for the first 24 hours post-fracture management following the as needed administration of the study drugs.

Secondary Outcome Measures

Acetaminophen doses [24 hours]
The secondary outcome variable is the number of breakthrough acetaminophen doses required/taken by the participant for the first 24 hours post-fracture management

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Exclusion Criteria:

patients with known hypersensitivity to either ibuprofen or morphine
chronic users of NSAIDS or opioids
fractures requiring operative management
associated injuries requiring analgesia
poor English fluency
pregnancy

Inclusion Criteria:

All patients aged 5 to 17 years with a non-operative forearm or distal radius fracture

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London Health Sciences Center	London	Ontario	Canada	N6A5W9

Sponsors and Collaborators

Naveen Poonai

Investigators

Principal Investigator: Naveen Poonai, MD, FRCPC, Lawson Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Naveen Poonai, Principal Investigator, Lawson Health Research Institute

ClinicalTrials.gov Identifier:

NCT01690780

Other Study ID Numbers:

R-11-340
18091

First Posted:

Sep 24, 2012

Last Update Posted:

Jul 16, 2014

Last Verified:

Jul 1, 2014

Keywords provided by Naveen Poonai, Principal Investigator, Lawson Health Research Institute

Additional relevant MeSH terms:

Fractures, Bone

Ibuprofen

Morphine

Study Results

No Results Posted as of Jul 16, 2014