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

NCT04523623 | Withdrawn

• 1 other identifier: OxyvsIbup2020
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Forearm Injuries; Pain, Acute; Pediatric ALL

Keywords

oxycodone; ibuprofen

Outcome Measures

Primary Outcomes (1)

• Pain change/difference

  An appreciable change in pain scores (by 2 points) from presentation to discharge

  180 minutes total

Study Arms (2)

Ibuprofen Group

EXPERIMENTAL

To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.

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.

Drug: Oxycodone

Interventions

Oxycodone DRUG

oxycodone 0.2mg/kg, max 10mg to be administered, randomized between that and Ibuprofen

Oxycodone Group

Ibuprofen DRUG

ibuprofen 10mg/kg, max 800mg, randomized between that and Oxycodone

Ibuprofen Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Publications (8)

• 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).

  BACKGROUND

• 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.

  PMID: 18772726 BACKGROUND

• 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. doi: 10.1017/s1481803500003468.

  PMID: 25358276 BACKGROUND

• 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.

  PMID: 29114833 BACKGROUND

• 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.

  PMID: 30810754 BACKGROUND

• 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.

  PMID: 25624387 BACKGROUND

• 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.

  PMID: 24904812 BACKGROUND

• 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.

  PMID: 29107409 BACKGROUND

MeSH Terms

Conditions

Forearm Injuries; Acute Pain; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Oxycodone; Ibuprofen

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 21, 2020
• Study Start: July 28, 2020
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: October 26, 2024

Record last verified: 2024-10