Pain Clinical Trial
Official title:
Adjunctive Oral Analgesia for Laceration Repair: Assessing Pain in a Pediatric Emergency Department
NCT number | NCT01268670 |
Other study ID # | 1005-052 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | December 29, 2010 |
Last updated | July 30, 2013 |
Start date | July 2012 |
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.
Status | Suspended |
Enrollment | 150 |
Est. completion date | |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 10 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospitals and Clinics of Minnesota | Minneapolis and St Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Children's Hospitals and Clinics of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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