- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01053637
Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Baylor College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hydrocodone/acetaminophen
Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.
|
0.17 mg/kg hydrocodone component to max of 10 mg.
If dose is vomited within 5 minutes, second dose may be administered.
Other Names:
|
Placebo Comparator: Sugar water
Placebo
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group
Time Frame: 5 minutes
|
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 repair.
If the procedure was completed, there were no scores recorded at that time point.
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale
Time Frame: 1 hour approximately (survey was given pre and post procedure so from 15 minutes to 1 hour after initial survey (or 5 minutes to 45 minutes after the procedure).
|
State-Trait Anxiety Inventory for Children - 20 questions with 3 answer options for each question. Scores range from 20 to 60 for state and 20 to 60 for trait with 60 being the higher (more or worse) anxiety on self-assessment. The VAS pain Scale from 0-10 was included in this older population as well. |
1 hour approximately (survey was given pre and post procedure so from 15 minutes to 1 hour after initial survey (or 5 minutes to 45 minutes after the procedure).
|
Visual Analog Scale (VAS) Pain Score for Children > 7 Years.
Time Frame: 30 minutes
|
Visual Analog Scale from 0-10 as marked on a 10 cm line. 0 no pain, 10 worst pain. A child >7 group marks their pain on the line, and a mm measurement is made. Power based on a change in the Visual Analog Scale (VAS) for children > 7 years. A change in pain score of 10 mm (95% Confidence Interval 7-12 mm) was considered to be clinically significant based upon a previous study. |
30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Corrie Chumpitazi, MD, Texas Childrens Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Lacerations
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Acetaminophen
- Hydrocodone
- Acetaminophen, hydrocodone drug combination
Other Study ID Numbers
- H-22684
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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