Upper Extremity FracturesNCT01690780
Oral Morphine Versus Ibuprofen
A study testing Oral morphine and Ibuprofen in people with Upper Extremity Fractures and Analgesia Post Fracture, run by Naveen Poonai at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Extremity Fractures, Analgesia Post Fracture
- What is being tested?
- Oral morphine and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All patients aged 5 to 17 years with a non-operative forearm or distal radius fracture
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Morphine Versus Ibuprofen for Post-fracture Pain Management in Children: a Randomized Controlled Study
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.
- Conditions
- Upper Extremity Fractures, Analgesia Post Fracture
- Being tested
- Oral morphine, Ibuprofen
- Keywords
- fracture, pediatric, oral morphine, ibuprofen
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral morphineDrug
oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours
IbuprofenDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Active comparator | Not described Receives: Drug: Ibuprofen |
| Oral morphine | Experimental | Not described Receives: Drug: Oral morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faces Pain scale - revised
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.
Measured: 30 minutes post intervention compared to baseline
Secondary outcomes (1)
Acetaminophen doses
The secondary outcome variable is the number of breakthrough acetaminophen doses required/taken by the participant for the first 24 hours post-fracture management
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naveen Poonai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naveen Poonai, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Naveen Poonai, MD, FRCPC, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690780
- Sponsor's protocol ID
- R-11-340
- Other IDs
- 18091
- Status last verified
- Jul 2014
- First submitted
- 13 Sep 2012
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Faught L, Elzagallaai AA, Tonial N, Ali S, Lepore N, Reardon J, Urquhart B, Ross C, Rieder MJ, Poonai N. Oral morphine pharmacokinetics in healthy children and the effect of genetic polymorphisms: An exploratory study. Paediatr Child Health. 2025 Oct 12;31(1):35-41. doi: 10.1093/pch/pxaf084. eCollection 2026 Feb.
PubMed 41630937Poonai N, Bhullar G, Lin K, Papini A, Mainprize D, Howard J, Teefy J, Bale M, Langford C, Lim R, Stitt L, Rieder MJ, Ali S. Oral administration of morphine versus ibuprofen to manage postfracture pain in children: a randomized trial. CMAJ. 2014 Dec 9;186(18):1358-63. doi: 10.1503/cmaj.140907. Epub 2014 Oct 27.
PubMed 25349008
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Morphine Versus Ibuprofen for Post-fracture Pain Management in Children: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01690780
- Acronym / sponsor ID
- R-11-340
- Conditions
- Upper Extremity Fractures, Analgesia Post Fracture
- Keywords
- fracture, pediatric, oral morphine, ibuprofen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Naveen PoonaiUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Active comparator | Drug: Ibuprofen |
| Oral morphine | Experimental | Drug: Oral morphine |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients aged 5 to 17 years with a non-operative forearm or distal radius fracture
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral morphineoral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours | Drug | Oral morphine |
| IbuprofenIbuprofen 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 | Drug | Ibuprofen |
Primary outcome
Faces Pain scale - revised
Time frame: 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.
1 secondary outcome
Acetaminophen doses
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Derived from this study: PubMed 41630937Faught L, Elzagallaai AA, Tonial N, Ali S, Lepore N, Reardon J, Urquhart B, Ross C, Rieder MJ, Poonai N. Oral morphine pharmacokinetics in healthy children and the effect of genetic polymorphisms: An exploratory study. Paediatr Child Health. 2025 Oct 12;31(1):35-41. doi: 10.1093/pch/pxaf084. eCollection 2026 Feb.
- Derived from this study: PubMed 25349008Poonai N, Bhullar G, Lin K, Papini A, Mainprize D, Howard J, Teefy J, Bale M, Langford C, Lim R, Stitt L, Rieder MJ, Ali S. Oral administration of morphine versus ibuprofen to manage postfracture pain in children: a randomized trial. CMAJ. 2014 Dec 9;186(18):1358-63. doi: 10.1503/cmaj.140907. Epub 2014 Oct 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveen Poonai, MD, FRCPC principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral morphine and Ibuprofen in people with Upper Extremity Fractures and Analgesia Post Fracture, run by Naveen Poonai at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faces Pain scale - revised (time frame: 30 minutes post intervention compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01690780, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.