NCT01268670

The Addition of Oral Analgesics to LET During Laceration Repair

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Children's Hospitals and Clinics of Minnesota · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laceration
• Pain

Interventions

Type	Name	Description
DRUG	Ibuprofen	Subjects will receive topical LET and oral ibuprofen.
DRUG	Oxycodone	Subjects will receive topical LET and oral oxycodone.
OTHER	Placebo	Subjects will receive topical LET and oral placebo.

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-07-01
• First posted: 2010-12-31
• Last updated: 2013-07-31

Locations

1 site across 1 country: United States