N/A
Completed N=85
Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair
Children · Lacerations · Procedures · Child
Source: ClinicalTrials.gov NCT01053637 ↗
Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group — 5; 7 units on a scale — p=0.05
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group |
5; 7 | 0.05 |
| SECONDARY Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale |
34.5; 38.0; 26.0; 29.0; 0.1; 0.5 | 0.05 |
| SECONDARY Visual Analog Scale (VAS) Pain Score for Children > 7 Years. |
0.5; 0.85; 0.1; 0.5; 0.0; 0.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01053637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.