Pain Clinical Trial
Official title:
Adjunctive Oral Analgesia for Laceration Repair: Assessing Pain in a Pediatric Emergency Department
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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