The Addition of Oral Analgesics to LET During Laceration Repair

NCT ID: NCT01268670

Last Updated: 2013-07-31

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31

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.

Conditions

Laceration; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ibuprofen

Subjects will receive topical LET and oral ibuprofen.

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

Subjects will receive topical LET and oral ibuprofen.

Oxycodone

Subjects will receive topical LET and oral oxycodone.

Group Type: ACTIVE_COMPARATOR

Oxycodone

Intervention Type: DRUG

Subjects will receive topical LET and oral oxycodone.

Placebo

Subjects will receive topical LET and oral placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Subjects will receive topical LET and oral placebo.

Interventions

Ibuprofen

Subjects will receive topical LET and oral ibuprofen.

Intervention Type: DRUG

Oxycodone

Subjects will receive topical LET and oral oxycodone.

Intervention Type: DRUG

Placebo

Subjects will receive topical LET and oral placebo.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospitals and Clinics of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Heidi Vander Velden

Senior Clinical Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospitals and Clinics of Minnesota

Minneapolis and Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

1005-052

Identifier Type: -

Identifier Source: org_study_id