The Addition of Oral Analgesics to LET During Laceration Repair

Children's Hospitals and Clinics of Minnesota

Status: Suspended

Conditions: Laceration; Pain

Treatments: Other: Placebo; Drug: Oxycodone; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT01268670

1005-052

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

Ibuprofen

Active Comparator group

Description:

Subjects will receive topical LET and oral ibuprofen.

Treatment:

Drug: Ibuprofen

Oxycodone

Active Comparator group

Description:

Subjects will receive topical LET and oral oxycodone.

Treatment:

Drug: Oxycodone

Placebo

Placebo Comparator group

Description:

Subjects will receive topical LET and oral placebo.

Treatment:

Other: Placebo