At a glance
ClinicalIndex Comparison Record- ✓Age 2 to 17 years
- ✓Laceration of skin and/or subcutaneous tissue requiring sutures
- ✓ASA score I or II
- ✕Major injuries beyond the laceration (suspected fracture, intracranial, intrathoracic, or intraabdominal bleeding or organ injury)
- ✕Abnormal neurologic examination or head injury
- ✕Severe congenital heart disease
- ✕Pregnancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department
In Brief
A clinical study evaluating hydrocodone/acetaminophen and Sugar water for Children and 4 related conditions. Completed, enrolled 85 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered.
An equal volume of sugar water will be dispensed, as for the weight based 0.17 mg/kg hydrocodone solution given for the study drug