The Addition of Oral Analgesics to LET During Laceration Repair

Study Overview
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Brief Summary
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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.

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

Conditions
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Laceration, Pain

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Oxycodone
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ibuprofen<br>Subjects will receive topical LET and oral ibuprofen. | Drug: Ibuprofen<br>* Subjects will receive topical LET and oral ibuprofen.<br>|
| Active Comparator: Oxycodone<br>Subjects will receive topical LET and oral oxycodone. | Drug: Oxycodone<br>* Subjects will receive topical LET and oral oxycodone.<br>|
| Placebo Comparator: Placebo<br>Subjects will receive topical LET and oral placebo. | Other: Placebo<br>* Subjects will receive topical LET and oral placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

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