Recruiting

Narcotic vs. Non-narcotic

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT03375593

Conditions

Distal Radius Fracture

Pain Management

Metacarpal Fracture

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hydrocodone 5Mg/Acetaminophen 500Mg Tab

Acetaminophen 500Mg Tab

Ibuprofen 600 mg tab

Study Details

Brief summary:

The purpose of this study is to evaluate two drug options for pain control in patients following wrist injury. Participants will be randomized to one of the 2 pain relief treatments to determine what treatment provides the most effective pain relief

Conditions

Distal Radius Fracture

Pain Management

Metacarpal Fracture

Study ID

NCT03375593

Start date

Aug 1, 2019

Status verified date

Feb, 2021

Completion date

Oct 1, 2022

Anticipated

Primary completion date

Oct 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients 18 and older undergoing non-operative management of a hand or wrist fracture will be considered eligible.
  • Able to read and speak English

Exclusion Criteria:

  • pain exceeding 7/10 on numeric rating scale or 35/50 on PRWE pain scale at enrollment
  • nerve injury
  • surgeon decision that surgery is required
  • history of chronic opioid use
  • documented or suspected substance abuse
  • individuals currently on daily use of ibuprofen, acetaminophen or other pain-altering medication including medications like Neurontin (gabapentin) and Ultram (tramadol)
  • individuals with documented or suspected chronic pain syndrome, reported allergy or adverse reaction to hydrocodone, acetaminophen, or ibuprofen
  • history or symptoms of serious medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease)
  • patients with active peptic ulcer disease (history of severe heartburn)
  • symptoms of infection
  • pregnant or lactating women
  • diagnosis of cognitive impairment
  • unable to provide informed consent
  • unable or unwilling to fill out the forms
  • prior fracture in same hand
  • on Coumadin or Plavix
  • other medical or psychological health conditions that preclude them from receiving either intervention
  • or unable to return for follow-up visits

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Narcotic

Hydrocodone 5mg/Acetaminophen 500 mg Tab

experimental: Non Narcotic

Ibuprofen 600mg Tab + acetaminophen 500 mg Tab

Interventions

Hydrocodone 5Mg/Acetaminophen 500Mg Tab

tablet

Acetaminophen 500Mg Tab

tablet

Ibuprofen 600 mg tab

tablet

Primary outcome measure

  • Pain [ Time Frame: 0-2 weeks ]

Central Contacts and Locations

Central contacts

Joy C MacDermid, PhD

519-646-6100jmacderm@uwo.ca

Katrina Munro, CRA

519-646-6100katrina.munro@sjhc.london.on.ca

Locations

St. Joseph Health Care

Recruiting

London, Ontario, Canada, N6A 4L6

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Mar 1, 2021

Last verified

Feb, 2021

Keywords

  • pain management
  • RCT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2021-03-01.