Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair
This study is ongoing, but not recruiting participants.
Sponsor:
Texas Children's Hospital
Information provided by (Responsible Party):
Corrie Chumpitazi, Texas Children's Hospital
ClinicalTrials.gov Identifier:
NCT01053637
First received: January 20, 2010
Last updated: June 1, 2012
Last verified: June 2012
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Purpose
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
| Condition | Intervention |
|---|---|
|
Pediatrics Lacerations Sutures Child Pain |
Drug: hydrocodone/acetaminophen Drug: Sugar water |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department |
Resource links provided by NLM:
Further study details as provided by Texas Children's Hospital:
Primary Outcome Measures:
- Statistical difference in pain scores in children during laceration repair between study and placebo group [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Statistical difference in State-Trait Anxiety Inventory for Children (STAIC) scores for children age 8-17 years during laceration repair [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 85 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | November 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Hydrocodone/acetaminophen
Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.
|
Drug: hydrocodone/acetaminophen
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 |
Drug: Sugar water
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
|
Detailed Description:
A prospective, double-blind, placebo-controlled, randomized clinical trial in a tertiary care pediatric emergency department with an annual census of 80,000 visits per year. Patients will be randomized by a randomization table with block randomization in the pharmacy to the oral narcotic or placebo group, and the pharmacist will be the only person aware of the randomization status of the patient. Allocation concealment will be ensured by opaque, sealed envelopes kept in the Emergency Department Pharmacy. Guardians of patients age 2 to 17 years of age will be consented for enrollment.
Eligibility| Ages Eligible for Study: | 2 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053637
Locations
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Texas Children's Hospital
Investigators
| Principal Investigator: | Corrie Chumpitazi, MD | Texas Childrens Hospital |
More Information
No publications provided
| Responsible Party: | Corrie Chumpitazi, Assistant Professor, Texas Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01053637 History of Changes |
| Other Study ID Numbers: | H-22684 |
| Study First Received: | January 20, 2010 |
| Last Updated: | June 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Texas Children's Hospital:
|
lacerations sutures pediatrics |
child pain Anxiety |
Additional relevant MeSH terms:
|
Anxiety Disorders Lacerations Mental Disorders Wounds and Injuries Acetaminophen Acetaminophen, hydrocodone drug combination Hydrocodone Oxycodone Narcotics Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics, Opioid Central Nervous System Depressants Antitussive Agents Respiratory System Agents Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013