Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 10/14/2017 |
| Start Date: | February 2009 |
| End Date: | May 2015 |
Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department
The purpose of this study is:
- To determine whether oral narcotic medication versus placebo improves the pain and
anxiety scores for pediatric patients requiring laceration repair in the pediatric
emergency department and receiving the standard of care with lidocaine treatment
- To evaluate for a statistical difference in pain scores in children during laceration
repair
- To evaluate for a statistical difference in State-Trait Anxiety Inventory for Children
(STAIC) scores during laceration repair
- To determine whether oral narcotic medication versus placebo improves the pain and
anxiety scores for pediatric patients requiring laceration repair in the pediatric
emergency department and receiving the standard of care with lidocaine treatment
- To evaluate for a statistical difference in pain scores in children during laceration
repair
- To evaluate for a statistical difference in State-Trait Anxiety Inventory for Children
(STAIC) scores during laceration repair
A prospective, double-blind, placebo-controlled, randomized clinical trial in a tertiary care
pediatric emergency department with an annual census of 80,000 visits per year. Patients will
be randomized by a randomization table with block randomization in the pharmacy to the oral
narcotic or placebo group, and the pharmacist will be the only person aware of the
randomization status of the patient. Allocation concealment will be ensured by opaque, sealed
envelopes kept in the Emergency Department Pharmacy. Guardians of patients age 2 to 17 years
of age will be consented for enrollment.
pediatric emergency department with an annual census of 80,000 visits per year. Patients will
be randomized by a randomization table with block randomization in the pharmacy to the oral
narcotic or placebo group, and the pharmacist will be the only person aware of the
randomization status of the patient. Allocation concealment will be ensured by opaque, sealed
envelopes kept in the Emergency Department Pharmacy. Guardians of patients age 2 to 17 years
of age will be consented for enrollment.
Inclusion Criteria:
- Age 2 to 17 years
- Laceration of the skin and/or subcutaneous tissue requiring sutures
- American Society of Anesthesiologists (ASA) score of I or II
Exclusion Criteria:
- Major injuries in addition to laceration (suspected fracture, intracranial,
intrathoracic, or intraabdominal bleeding or organ injury)
- Abnormal neurologic examination (such as head injury)
- Severe congenital heart disease
- Pregnancy
- Known opiate or acetaminophen allergy
- Require conscious sedation
- Have had narcotic or acetaminophen administration within 4 previous hours
We found this trial at
1
site
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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