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NCT01053637 · ClinicalTrials.gov registry record · NA
Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair
A NA study of Pain and Children, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 85
- Enrollment target
- 1
- Study location
NCT01053637: Completed NA study of Pain and Children, sponsored by Baylor College of Medicine.
NCT01053637 is a NA study of Pain and Children that has completed, run by Baylor College of Medicine. The registered enrollment target is 85 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01053637, a NA study of Pain and Children, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 85 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Children's Hospital of Eastern Ontario Pain Scale, for children 2-7 years. This score ranks 6 categories: Cry, Facial expression, Verbal Response, Torso movement, Touch, and Leg movement. The scale varies by each category from 0-2 or 1-2 or 1-3; such that a minimum score is 4 (no pain) and a maximum score is 13 signifying greatest pain. This results in a 10 point scale of possible results, and is rated by an objective observer; the child life specialist at the bedside during the laceration repai
Conditions Studied
Interventions
- DRUG hydrocodone/acetaminophen
- DRUG Sugar water
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2009-02 |
| Est. Completion | 2015-05 |
| Phase | NA |
What the finished NCT01053637 record still lists
NCT01053637 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (72% lower).
The record links to 5 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which hydrocodone/acetaminophen is the first listed.
NCT01053637 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01053637 about?
NCT01053637 is a clinical study titled "Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair". 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 ...
What is the current status of trial NCT01053637?
This trial is currently completed. It is a NA study. The enrollment target is 85 participants. The study started on 2009-02. Estimated completion is 2015-05.
What conditions does trial NCT01053637 study?
This clinical trial studies the following conditions: Pain, Children, Child, Lacerations, Procedures.
What interventions are being tested in trial NCT01053637?
The interventions under investigation include: hydrocodone/acetaminophen (DRUG), Sugar water (DRUG).
Who is sponsoring clinical trial NCT01053637?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01053637 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01053637's enrollment target sits among peer trials
85 187th of 374 higher than 188 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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