Back to resultsPain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair
Primary Purpose
Children, Lacerations, Procedures
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hydrocodone/acetaminophen
Sugar water
Sponsored by
About this trial
This is an interventional treatment trial for Children focused on measuring lacerations, sutures, pediatrics, child, pain, Anxiety
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
Sites / Locations
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydrocodone/acetaminophen
Sugar water
Arm Description
Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.
Placebo
Outcomes
Primary Outcome Measures
Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group
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.
Secondary Outcome Measures
Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale
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.
Visual Analog Scale (VAS) Pain Score for Children > 7 Years.
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.
Full Information
NCT ID
NCT01053637
First Posted
January 20, 2010
Last Updated
August 2, 2021
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01053637
Brief Title
Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair
Official Title
Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Lacerations, Procedures, Child, Pain
Keywords
lacerations, sutures, pediatrics, child, pain, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrocodone/acetaminophen
Arm Type
Experimental
Arm Description
Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.
Arm Title
Sugar water
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
hydrocodone/acetaminophen
Other Intervention Name(s)
Lortab, Vicodin
Intervention Description
0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered.
Intervention Type
Drug
Intervention Name(s)
Sugar water
Intervention Description
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
Primary Outcome Measure Information:
Title
Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group
Description
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.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale
Description
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.
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).
Title
Visual Analog Scale (VAS) Pain Score for Children > 7 Years.
Description
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.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corrie Chumpitazi, MD
Organizational Affiliation
Texas Childrens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair
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