An interventional study of hydrocodone/acetaminophen and Sugar water in Children, Lacerations and Procedures, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-08-25.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
The purpose of this study is:
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.
133 studies on the registry are indexed under Lacerations; 29 are open to participants now.
This study's enrollment of 85 is close to the median of 79 across 106 interventional studies indexed under Lacerations.
Browse Lacerations studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.
Drug: hydrocodone/acetaminophen
Placebo
Drug: Sugar water
0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered.
Also known as: Lortab, Vicodin
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
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.
Time frame: 5 minutes
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.
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).
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.
Time frame: 30 minutes
| Milestone | Hydrocodone/Acetaminophen | Sugar Water |
|---|---|---|
| Started | 43 | 42 |
| Completed | 43 | 42 |
| Not completed | 0 | 0 |
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.
| units on a scale | Hydrocodone/Acetaminophen | Sugar Water |
|---|---|---|
| Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group | 5 (4 to 6.5) | 7 (5.25 to 10) |
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.
| units on a scale | Hydrocodone/Acetaminophen | Sugar Water |
|---|---|---|
| State Anxiety Pre-Test | 34.5 (31.0 to 40.75) | 38.0 (32.5 to 41.75) |
| State Anxiety Post-Test | 26.0 (24.0 to 30.0) | 29.0 (21.50 to 32.50) |
| VAS Pain Score at 5 minutes | 0.1 (0.0 to 4.23) | 0.5 (0.0 to 1.2) |
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.
| score on a scale | Hydrocodone/Acetaminophen | Sugar Water |
|---|---|---|
| Baseline | 0.5 (0.0 to 5.30) | 0.85 (0.0 to 4.85) |
| 5 minutes | 0.1 (0.0 to 4.23) | 0.5 (0.0 to 1.20) |
| 10 minutes | 0.0 (0.0 to 2.00) | 0.0 (0.0 to 1.60) |
| 15 minutes | 0.0 (0.0 to 3.18) | 0.0 (0.0 to 0.75) |
| Procedure Finish | 0.0 (0.0 to 0.0) | 0.0 (0.0 to 0.0) |
Collected over Adverse events were collected from the time of enrollment through hospital discharge for the specific emergency department visit during which the patient was enrolled, and chart reviewed for return visit up to 72 hours from discharge.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hydrocodone/Acetaminophen | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Sugar Water | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Age, Continuous(years) | Intervention | Placebo | Total |
|---|---|---|---|
| Median | 5.25 (3.75 to 6.74) | 4.87 (3.57 to 6.27) | 5.1 (3.6 to 6.5) |
| Sex: Female, Male(Participants) | Intervention | Placebo | Total |
|---|---|---|---|
| Female | 7 | 16 | 23 |
| Male | 36 | 26 | 62 |
| Race/Ethnicity, Customized(participants) | Intervention | Placebo | Total |
|---|---|---|---|
| African-American | 12 | 8 | 20 |
| Caucasian | 4 | 10 | 14 |
| Hispanic | 25 | 23 | 48 |
| Other | 2 | 1 | 3 |
| Region of Enrollment(participants) | Intervention | Placebo | Total |
|---|---|---|---|
| United States | 43 | 42 | 85 |
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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