Children, Lacerations, Procedures, Child, Pain
Conditions
Keywords
lacerations, sutures, pediatrics, child, pain, Anxiety
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.
Interventions
0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered.
DRUGSugar 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
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain 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). | 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Hydrocodone/acetaminophen suspension (taste/color-matched) | 43 |
| Placebo Sugar solution | 42 |
| Total | 85 |
Baseline characteristics
| Characteristic | Placebo | Intervention | Total |
|---|---|---|---|
| Age, Continuous | 4.87 years | 5.25 years | 5.1 years |
| Race/Ethnicity, Customized African-American | 8 participants | 12 participants | 20 participants |
| Race/Ethnicity, Customized Caucasian | 10 participants | 4 participants | 14 participants |
| Race/Ethnicity, Customized Hispanic | 23 participants | 25 participants | 48 participants |
| Race/Ethnicity, Customized Other | 1 participants | 2 participants | 3 participants |
| Region of Enrollment United States | 42 participants | 43 participants | 85 participants |
| Sex: Female, Male Female | 16 Participants | 7 Participants | 23 Participants |
| Sex: Female, Male Male | 26 Participants | 36 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 42 |
| other Total, other adverse events | 0 / 43 | 0 / 42 |
| serious Total, serious adverse events | 0 / 43 | 0 / 42 |
Outcome results
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.
Time frame: 5 minutes
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hydrocodone/Acetaminophen | Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group | 5 units on a scale |
| Sugar Water | Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group | 7 units on a scale |
Comparison: 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 or worst pain.p-value: 0.05Fisher Exact
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.
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).
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hydrocodone/Acetaminophen | 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 Anxiety Pre-Test | 34.5 units on a scale |
| Hydrocodone/Acetaminophen | 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 Anxiety Post-Test | 26.0 units on a scale |
| Hydrocodone/Acetaminophen | Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale | VAS Pain Score at 5 minutes | 0.1 units on a scale |
| Sugar Water | 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 Anxiety Pre-Test | 38.0 units on a scale |
| Sugar Water | 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 Anxiety Post-Test | 29.0 units on a scale |
| Sugar Water | Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale | VAS Pain Score at 5 minutes | 0.5 units on a scale |
Comparison: State-Trait Anxiety Inventory for Children pre vs. post procedure for matched pairs. Higher numbers indicated higher state anxiety. State Trait Anxiety Inventory for Children (STAIC) scores pre vs. post procedure for matched pairs. A lower STAIC score indicates less anxiety and a greater score indicates more anxiety based on Likert-type scales and analyzed using nonparametric testing.p-value: 0.05Wilcoxon (Mann-Whitney)
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.
Time frame: 30 minutes
Population: 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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hydrocodone/Acetaminophen | Visual Analog Scale (VAS) Pain Score for Children > 7 Years. | 5 minutes | 0.1 score on a scale |
| Hydrocodone/Acetaminophen | Visual Analog Scale (VAS) Pain Score for Children > 7 Years. | 15 minutes | 0.0 score on a scale |
| Hydrocodone/Acetaminophen | Visual Analog Scale (VAS) Pain Score for Children > 7 Years. | 10 minutes | 0.0 score on a scale |
| Hydrocodone/Acetaminophen | Visual Analog Scale (VAS) Pain Score for Children > 7 Years. | Procedure Finish | 0.0 score on a scale |
| Hydrocodone/Acetaminophen | Visual Analog Scale (VAS) Pain Score for Children > 7 Years. | Baseline | 0.5 score on a scale |
| Sugar Water | Visual Analog Scale (VAS) Pain Score for Children > 7 Years. | Procedure Finish | 0.0 score on a scale |
| Sugar Water | Visual Analog Scale (VAS) Pain Score for Children > 7 Years. | Baseline | 0.85 score on a scale |
| Sugar Water | Visual Analog Scale (VAS) Pain Score for Children > 7 Years. | 5 minutes | 0.5 score on a scale |
| Sugar Water | Visual Analog Scale (VAS) Pain Score for Children > 7 Years. | 10 minutes | 0.0 score on a scale |
| Sugar Water | Visual Analog Scale (VAS) Pain Score for Children > 7 Years. | 15 minutes | 0.0 score on a scale |