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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrocodone/acetaminophen | Experimental | Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone. |
|
| Sugar water | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydrocodone/acetaminophen | Drug | 0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 minutes |
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corrie Chumpitazi, MD | Texas Childrens Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydrocodone/Acetaminophen | Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone. 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. |
| FG001 | Sugar Water | Placebo 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Hydrocodone/acetaminophen suspension (taste/color-matched) |
| BG001 | Placebo | Sugar solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The 2-7 year old population at primary outcome time point of 5 minutes. This 2-7 year old population: randomized 25 in each arm (50 total) but 5 had missing pain scores due to child life specialist availability at the time of repair. Older population had 35 patients enrolled, but 1 in the placebo group was excluded for missing pain scores. | Posted | Median | Inter-Quartile Range | units on a scale | 5 minutes |
|
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.
Any adverse event was reported directly to the study PI.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hydrocodone/Acetaminophen | Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corrie E. Chumpitazi | BAYLOR COLLEGE OF MEDICINE | 832 824-1353 | corriec@bcm.edu |
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| ID | Term |
|---|---|
| D022125 | Lacerations |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C514822 | oxycodone-acetaminophen |
| C083640 | acetaminophen, hydrocodone drug combination |
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|
| Sugar water | Drug | 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 |
|
| 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. | 30 minutes |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Hydrocodone/Acetaminophen | Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone. 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. |
| OG001 | Sugar Water | Placebo 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 |
|
|
|
| Secondary | 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. | State-Trait Anxiety Inventory for Children (STAIC) which is a 20 question tool, low score no anxiety and high score more anxiety. This test was only used for the 34 patients in the >7 years (8-17 years) category as this scale is validated in that population. The VAS Pain score was measured as well. | Posted | Median | Inter-Quartile Range | units on a scale | 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). |
|
|
|
|
| Secondary | 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. | 1 placebo (sugar water) patient required sedation and 1 placebo (sugar water) patient had missing pain scores, so 14 patients for analysis. For the hydrocodone/acetaminophen group, baseline VAS score was not available for 1 participant. If the procedure was completed, there were no scores recorded at that time point (i.e. 20 minutes). | Posted | Median | Inter-Quartile Range | score on a scale | 30 minutes |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Sugar Water | Placebo 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 | 0 | 42 | 0 | 42 | 0 | 42 |
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| D001523 | Mental Disorders |
| VAS Pain Score at 5 minutes |
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| 5 minutes |
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| 10 minutes |
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| 15 minutes |
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| 20 minutes |
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| Procedure Finish |
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