ChildrenNCT01053637
Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair
A study testing hydrocodone/acetaminophen and Sugar water in people with Children and Lacerations, run by Baylor College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Children, Lacerations, Procedures
- What is being tested?
- hydrocodone/acetaminophen and Sugar water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department
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
Read the 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.
- Conditions
- Children, Lacerations, Procedures, Child, Pain
- Being tested
- hydrocodone/acetaminophen, Sugar water
- Keywords
- lacerations, sutures, pediatrics, child, pain, Anxiety
- Medical subject headings
- Lacerations, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocodone/acetaminophenDrug
Also called Lortab, Vicodin
0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered.
Sugar waterDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Hydrocodone/acetaminophen | Experimental | Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone. Receives: Drug: hydrocodone/acetaminophen |
| Sugar water | Placebo comparator | Placebo Receives: Drug: Sugar water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Secondary outcomes (2)
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.
Measured: 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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startFeb 2009
- Primary completionJan 2012
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corrie Chumpitazi, Baylor College of Medicine
- Investigators
- Corrie Chumpitazi, MD, Principal investigator, Texas Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053637
- Sponsor's protocol ID
- H-22684
- Status last verified
- Aug 2021
- First submitted
- 20 Jan 2010
- Last updated
- 25 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT01053637
- Acronym / sponsor ID
- H-22684
- Conditions
- Children, Lacerations, Procedures, Child, Pain
- Keywords
- lacerations, sutures, pediatrics, child, pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Posted 25 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocodone/acetaminophen | Experimental | Drug: hydrocodone/acetaminophenPatients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone. |
| Sugar water | Placebo comparator | Drug: Sugar waterPlacebo |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrocodone/acetaminophenAlso: Lortab, Vicodin0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered. | Drug | Hydrocodone/acetaminophen |
| Sugar waterAn equal volume of sugar water will be dispensed, as for the weight based 0.17 mg/kg hydrocodone solution given for the study drug | Drug | Sugar water |
Primary outcome
Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group
Time frame: 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.
2 secondary outcomes
Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale
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.
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corrie Chumpitazi, MD principal investigator
Texas Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrocodone/acetaminophen and Sugar water in people with Children and Lacerations, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.