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The Addition of Oral Analgesics to LET During Laceration Repair

NCT01268670 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2013-07-31

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Children's Hospitals and Clinics of Minnesota

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-07-31

Countries

  • United States

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01268670 on ClinicalTrials.gov