Clinical Trial: The Addition of Oral Analgesics to LET During Laceration Repair

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Adjunctive Oral Analgesia for Laceration Repair: Assessing Pain in a Pediatric Emergency Department

Brief Summary:

Background Approximately 30 million children are treated in emergency departments each year in the United States, of which two to three million are children presenting with lacerations. Topical numbing medication is the standard of care in children with regard to pain control during laceration repair. While topical numbing medications are effective, children often require further pain control during laceration repair in the form of an injected numbing medication, which in itself is painful. No evidence currently exists regarding the concurrent use of oral pain medications to combat laceration procedural pain.

Research Question Does the addition of ibuprofen or oxycodone to lidocaine, epinephrine, and tetracaine (LET) topical anesthetic provide more effective pain control than LET alone during laceration repair?

Design This is a double-blinded, randomized-controlled study.

Methods Subjects in all three groups will receive topical anesthetic. In addition to topical anesthetic, two groups of children will receive either of two oral analgesics, ibuprofen or oxycodone, while the third group will receive a placebo.

Detailed Summary:
Sponsor: Children's Hospitals and Clinics of Minnesota

Current Primary Outcome: Pain scores [ Time Frame: At Triage, after first suture, and the worst during the procedure ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Hospitals and Clinics of Minnesota

Dates:
Date Received: December 29, 2010
Date Started: July 2012
Date Completion:
Last Updated: July 30, 2013
Last Verified: July 2013