The Addition of Oral Analgesics to LET During Laceration Repair

Not Applicable

Suspended

• Conditions: Laceration; Pain
• Interventions: Drug: Oxycodone; Other: Placebo; Drug: Ibuprofen

• Registration Number: NCT01268670
• Lead Sponsor: Children's Hospitals and Clinics of Minnesota

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 Description

Not available

Study Timeline

• Study First Submitted: 2010-12-29
• Study First Submitted QC: 2010-12-29
• Study First Posted: 2010-12-31
• Study Start: 2012-07
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Last Update Submitted: 2013-07-30
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• English-speaking patients
• Patients 4 years of age up to 10 years of age
• Patients seen in the ED needing simple facial laceration repair
• Patients with no chronic medical problems

Exclusion Criteria

• Any patient who's parent or primary caretaker refuses consent
• Any patient who's parent or primary caretaker needs an interpreter
• Any child with complex laceration(s) or bites
• Any child who has received pain medication at home in response to the facial laceration.
• Children needing procedural sedation
• Children with a known allergy to lidocaine, epinephrine, tetracaine, ibuprofen, or oxycodone
• Patients with known or pre-existing medical conditions where the study protocol cannot be used
• This includes any patient with a medical condition that prevents appropriate use of the pain scale
• It also includes patients with medical conditions that warrant the use of chronic medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone	Oxycodone	Subjects will receive topical LET and oral oxycodone.
Placebo	Placebo	Subjects will receive topical LET and oral placebo.
Ibuprofen	Ibuprofen	Subjects will receive topical LET and oral ibuprofen.

Primary Outcome Measures

Name	Time	Method
Pain scores	At Triage, after first suture, and the worst during the procedure	The use of adjunctive oral analgesics for facial/scalp laceration repair decrease pain scores more effectively than LET alone.

Trial Locations

Locations (1)

Children's Hospitals and Clinics of Minnesota; 🇺🇸 Minneapolis and St Paul, Minnesota, United States