drugset / Trial / NCT01053637
Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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
Timeline
- Start
- 2009-02
- Primary completion
- 2012-01
- Completion
- 2015-05
Outcome
Missed primary endpoint
registry analysis (superiority test); Hydrocodone/Acetaminophen vs Sugar Water; p = 0.05; Fisher Exact NCT01053637 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | hydrocodone/acetaminophen | Unknown | 0.17 mg/kg | Oral |
Indications
No indication recorded.