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NCT04523623 Clinical Trial

Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries

Pain, Acute Clinical Trial

Official title:
Oxycodone or Ibuprofen for Suspected Isolated Forearm Fractures in Pediatric Patients: A Randomized Noninferiority Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04523623
Other study ID # OxyvsIbup2020
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2020
Est. completion date February 2021

Study information
Verified date August 2020
Source Washington University School of Medicine
Contact John E Graham
Phone 314-273-2734
Email grahamje@wustl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date February 2021
Est. primary completion date February 2021
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria:

1. 6 to 17 year old children presenting for care in the St. Louis Children's Hospital Emergency Department

2. Suspected acute (within 24 hours) isolated forearm fracture at the time of initial Triage assessment

3. American Society of Anesthesiologist physical status (ASA-PS) classification of I or II

4. Child with parent or legal guardian.

Exclusion Criteria:

1. Multiple injuries

2. Known adverse reaction to either ibuprofen or oxycodone pts with abnormal bones or metabolic conditions that affect bones

3. Administration of any opioid within 2 hours prior to presentation

4. Non-English speaking

5. Foster care, police custody, presenting without legal guardian

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oxycodone
oxycodone 0.2mg/kg, max 10mg to be administered, randomized between that and Ibuprofen
• Ibuprofen
ibuprofen 10mg/kg, max 800mg, randomized between that and Oxycodone

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Washington University School of Medicine

References & Publications (8)

Chang 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. — View Citation

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. — View Citation

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).

Ilyas 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. — View Citation

Kelly 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. — View Citation

Kircher 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. — View Citation

Moradi 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. — View Citation

Tsze 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pain reduction An appreciable decrease in pain scores (2 point reduction) from presentation to discharge 180 minutes total
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