Forearm InjuriesNCT04523623
Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries
A study testing Oxycodone and Ibuprofen in people with Forearm Injuries and Pain, Acute, run by Washington University School of Medicine.
Trial summary
Children presenting to the Emergency Room with the chief complaint of forearm injury and/or pain will be randomized to receive oral Oxycodone or Ibuprofen to control pain. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Forearm Injuries, Pain, Acute, Pediatric ALL
- What is being tested?
- Oxycodone and Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2020to 21 Jun 2021
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 6 to 17 year old children presenting for care in the St. Louis Children's Hospital Emergency Department
- Suspected acute (within 24 hours) isolated forearm fracture at the time of initial Triage assessment
- American Society of Anesthesiologist physical status (ASA-PS) classification of I or II
- Child with parent or legal guardian.
Who cannot join
- Multiple injuries
- Known adverse reaction to either ibuprofen or oxycodone pts with abnormal bones or metabolic conditions that affect bones
- Administration of any opioid within 2 hours prior to presentation
- Non-English speaking
- Foster care, police custody, presenting without legal guardian
About this study
Official title: Oxycodone or Ibuprofen for Suspected Isolated Forearm Fractures in Pediatric Patients: A Randomized Noninferiority Trial
Children presenting to the Emergency Room with the chief complaint of forearm injury and/or pain will be randomized to receive oral Oxycodone or Ibuprofen to control pain.
Read the detailed description
A randomized, blinded cohort study. Consented patients will be randomized to receive either ibuprofen or oxycodone after initial RN patient assessment in Emergency Department Triage determines a need for radiographs to evaluate for possible forearm fracture. Pain assessment scores will be determined at Triage and at 30-minute intervals throughout the patient's course until the patient is discharged home or additional analgesic medication is administered.
- Conditions
- Forearm Injuries, Pain, Acute, Pediatric ALL
- Being tested
- Oxycodone, Ibuprofen
- Keywords
- oxycodone, ibuprofen
- Medical subject headings
- Forearm Injuries, Acute Pain, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
oxycodone 0.2mg/kg, max 10mg to be administered, randomized between that and Ibuprofen
IbuprofenDrug
ibuprofen 10mg/kg, max 800mg, randomized between that and Oxycodone
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen Group | Experimental | To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children. Receives: Drug: Ibuprofen |
| Oxycodone Group | Experimental | To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children. Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain change/difference
An appreciable change in pain scores (by 2 points) from presentation to discharge
Measured: 180 minutes total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start28 Jul 2020
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Why it stopped: Project canceled for other reason , describe: - Lack of enrollment Project canceled - lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Forearm InjuriesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523623
- Sponsor's protocol ID
- OxyvsIbup2020
- Status last verified
- Oct 2024
- First submitted
- 19 Aug 2020
- Last updated
- 26 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ibuprofen or oxycodone? An observational cohort study of post emergency department discharge management of children's fracture pain. Ali S., Drendel A.L., Rosychuk R.J., Le May S., McGrath P., Carleton B., Johnson D.W. Canadian Journal of Emergency Medicine 2016 18 Supplement 1 (S47).
Charney RL, Yan Y, Schootman M, Kennedy RM, Luhmann JD. Oxycodone versus codeine for triage pain in children with suspected forearm fracture: a randomized controlled trial. Pediatr Emerg Care. 2008 Sep;24(9):595-600. doi: 10.1097/PEC.0b013e3181850ca3.
PubMed 18772726Kircher J, Drendel AL, Newton AS, Dulai S, Vandermeer B, Ali S. Pediatric musculoskeletal pain in the emergency department: a medical record review of practice variation. CJEM. 2014 Nov;16(6):449-57. doi: 10.1017/s1481803500003468.
PubMed 25358276Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial. JAMA. 2017 Nov 7;318(17):1661-1667. doi: 10.1001/jama.2017.16190.
PubMed 29114833Ilyas AM, Miller AJ, Graham JG, Matzon JL. A Prospective, Randomized, Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone for Pain Management After Hand Surgery. Orthopedics. 2019 Mar 1;42(2):110-115. doi: 10.3928/01477447-20190221-02. Epub 2019 Feb 27.
PubMed 30810754Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
PubMed 25624387Moradi M, Esmaeili S, Shoar S, Safari S. Use of oxycodone in pain management. Anesth Pain Med. 2012 Spring;1(4):262-4. doi: 10.5812/aapm.4529. Epub 2012 Apr 1.
PubMed 24904812Tsze DS, von Baeyer CL, Pahalyants V, Dayan PS. Validity and Reliability of the Verbal Numerical Rating Scale for Children Aged 4 to 17 Years With Acute Pain. Ann Emerg Med. 2018 Jun;71(6):691-702.e3. doi: 10.1016/j.annemergmed.2017.09.009. Epub 2017 Nov 6.
PubMed 29107409
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxycodone or Ibuprofen for Suspected Isolated Forearm Fractures in Pediatric Patients: A Randomized Noninferiority Trial
- ClinicalTrials.gov ID
- NCT04523623
- Acronym / sponsor ID
- OxyvsIbup2020
- Conditions
- Forearm Injuries, Pain, Acute, Pediatric ALL
- Keywords
- oxycodone, ibuprofen
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project canceled for other reason , describe: - Lack of enrollment Project canceled - lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 21 Aug 2020 (actual)
- 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 presenting to the Emergency Room with the chief complaint of forearm injury and/or pain will be randomized to receive oral Oxycodone or Ibuprofen to control pain.
Detailed description
A randomized, blinded cohort study. Consented patients will be randomized to receive either ibuprofen or oxycodone after initial RN patient assessment in Emergency Department Triage determines a need for radiographs to evaluate for possible forearm fracture. Pain assessment scores will be determined at Triage and at 30-minute intervals throughout the patient's course until the patient is discharged home or additional analgesic medication is administered.
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 Group | Experimental | Drug: IbuprofenTo compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children. |
| Oxycodone Group | Experimental | Drug: OxycodoneTo compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 6 to 17 year old children presenting for care in the St. Louis Children's Hospital Emergency Department
- Suspected acute (within 24 hours) isolated forearm fracture at the time of initial Triage assessment
- American Society of Anesthesiologist physical status (ASA-PS) classification of I or II
- Child with parent or legal guardian.
Key exclusion criteria (5 listed)
- Multiple injuries
- Known adverse reaction to either ibuprofen or oxycodone pts with abnormal bones or metabolic conditions that affect bones
- Administration of any opioid within 2 hours prior to presentation
- Non-English speaking
- Foster care, police custody, presenting without legal guardian
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 |
|---|---|---|
| Oxycodoneoxycodone 0.2mg/kg, max 10mg to be administered, randomized between that and Ibuprofen | Drug | Oxycodone Group |
| Ibuprofenibuprofen 10mg/kg, max 800mg, randomized between that and Oxycodone | Drug | Ibuprofen Group |
Primary outcome
Pain change/difference
Time frame: 180 minutes total
An appreciable change in pain scores (by 2 points) from presentation to discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- BackgroundIbuprofen or oxycodone? An observational cohort study of post emergency department discharge management of children's fracture pain. Ali S., Drendel A.L., Rosychuk R.J., Le May S., McGrath P., Carleton B., Johnson D.W. Canadian Journal of Emergency Medicine 2016 18 Supplement 1 (S47).
- Background: PubMed 18772726Charney RL, Yan Y, Schootman M, Kennedy RM, Luhmann JD. Oxycodone versus codeine for triage pain in children with suspected forearm fracture: a randomized controlled trial. Pediatr Emerg Care. 2008 Sep;24(9):595-600. doi: 10.1097/PEC.0b013e3181850ca3.
- Background: PubMed 25358276Kircher J, Drendel AL, Newton AS, Dulai S, Vandermeer B, Ali S. Pediatric musculoskeletal pain in the emergency department: a medical record review of practice variation. CJEM. 2014 Nov;16(6):449-57. doi: 10.1017/s1481803500003468.
- Background: PubMed 29114833Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial. JAMA. 2017 Nov 7;318(17):1661-1667. doi: 10.1001/jama.2017.16190.
- Background: PubMed 30810754Ilyas AM, Miller AJ, Graham JG, Matzon JL. A Prospective, Randomized, Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone for Pain Management After Hand Surgery. Orthopedics. 2019 Mar 1;42(2):110-115. doi: 10.3928/01477447-20190221-02. Epub 2019 Feb 27.
- Background: PubMed 25624387Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
- Background: PubMed 24904812Moradi M, Esmaeili S, Shoar S, Safari S. Use of oxycodone in pain management. Anesth Pain Med. 2012 Spring;1(4):262-4. doi: 10.5812/aapm.4529. Epub 2012 Apr 1.
- Background: PubMed 29107409Tsze DS, von Baeyer CL, Pahalyants V, Dayan PS. Validity and Reliability of the Verbal Numerical Rating Scale for Children Aged 4 to 17 Years With Acute Pain. Ann Emerg Med. 2018 Jun;71(6):691-702.e3. doi: 10.1016/j.annemergmed.2017.09.009. Epub 2017 Nov 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Oxycodone and Ibuprofen in people with Forearm Injuries and Pain, Acute, run by Washington University School of Medicine.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pain change/difference (time frame: 180 minutes total). 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 NCT04523623, which also lists 8 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 26 Oct 2024.