LacerationNCT01268670
The Addition of Oral Analgesics to LET During Laceration Repair
A study testing Ibuprofen and Oxycodone in people with Laceration and Pain, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial summary
Background Approximately 30 million children are treated in emergency departments each year in the United States, of which two to three million are children presenting with lacerations. Topical numbing medication is the standard of care in children with regard to pain control during laceration repair. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Laceration, Pain
- What is being tested?
- Ibuprofen and Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- English-speaking patients
- Patients 4 years of age up to 10 years of age
- Patients seen in the ED needing simple facial laceration repair
- Patients with no chronic medical problems
Who cannot join
- Any patient who's parent or primary caretaker refuses consent
- Any patient who's parent or primary caretaker needs an interpreter
- Any child with complex laceration(s) or bites
- Any child who has received pain medication at home in response to the facial laceration.
- Children needing procedural sedation
- Children with a known allergy to lidocaine, epinephrine, tetracaine, ibuprofen, or oxycodone
Show all 9Show fewer
- Patients with known or pre-existing medical conditions where the study protocol cannot be used
- This includes any patient with a medical condition that prevents appropriate use of the pain scale
- It also includes patients with medical conditions that warrant the use of chronic medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospitals and Clinics of Minnesota
Minneapolis and Saint Paul, Minnesota
About this study
Official title: Adjunctive Oral Analgesia for Laceration Repair: Assessing Pain in a Pediatric Emergency Department
Background Approximately 30 million children are treated in emergency departments each year in the United States, of which two to three million are children presenting with lacerations. Topical numbing medication is the standard of care in children with regard to pain control during laceration repair. While topical numbing medications are effective, children often require further pain control during laceration repair in the form of an injected numbing medication, which in itself is painful. No evidence currently exists regarding the concurrent use of oral pain medications to combat laceration procedural pain.
Research Question Does the addition of ibuprofen or oxycodone to lidocaine, epinephrine, and tetracaine (LET) topical anesthetic provide more effective pain control than LET alone during laceration repair?
Read more
Design This is a double-blinded, randomized-controlled study.
Methods Subjects in all three groups will receive topical anesthetic. In addition to topical anesthetic, two groups of children will receive either of two oral analgesics, ibuprofen or oxycodone, while the third group will receive a placebo.
- Conditions
- Laceration, Pain
- Medical subject headings
- Lacerations, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Subjects will receive topical LET and oral ibuprofen.
OxycodoneDrug
Subjects will receive topical LET and oral oxycodone.
PlaceboOther
Subjects will receive topical LET and oral placebo.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Active comparator | Subjects will receive topical LET and oral ibuprofen. Receives: Drug: Ibuprofen |
| Oxycodone | Active comparator | Subjects will receive topical LET and oral oxycodone. Receives: Drug: Oxycodone |
| Placebo | Placebo comparator | Subjects will receive topical LET and oral placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
The use of adjunctive oral analgesics for facial/scalp laceration repair decrease pain scores more effectively than LET alone.
Measured: At Triage, after first suture, and the worst during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startJul 2012
- Primary completionJul 2013 (estimated)
Why it stopped: This study is currently suspended due to transition of the investigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LacerationStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Vander Velden, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268670
- Sponsor's protocol ID
- 1005-052
- Status last verified
- Jul 2013
- First submitted
- 29 Dec 2010
- Last updated
- 31 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Oral Analgesia for Laceration Repair: Assessing Pain in a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT01268670
- Acronym / sponsor ID
- 1005-052
- Conditions
- Laceration, Pain
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: This study is currently suspended due to transition of the investigator.
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (estimated)
- First posted
- 31 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background Approximately 30 million children are treated in emergency departments each year in the United States, of which two to three million are children presenting with lacerations. Topical numbing medication is the standard of care in children with regard to pain control during laceration repair. While topical numbing medications are effective, children often require further pain control during laceration repair in the form of an injected numbing medication, which in itself is painful. No evidence currently exists regarding the concurrent use of oral pain medications to combat laceration procedural pain.
Research Question Does the addition of ibuprofen or oxycodone to lidocaine, epinephrine, and tetracaine (LET) topical anesthetic provide more effective pain control than LET alone during laceration repair?
Design This is a double-blinded, randomized-controlled study.
Methods Subjects in all three groups will receive topical anesthetic. In addition to topical anesthetic, two groups of children will receive either of two oral analgesics, ibuprofen or oxycodone, while the third group will receive a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Active comparator | Drug: IbuprofenSubjects will receive topical LET and oral ibuprofen. |
| Oxycodone | Active comparator | Drug: OxycodoneSubjects will receive topical LET and oral oxycodone. |
| Placebo | Placebo comparator | Other: PlaceboSubjects will receive topical LET and oral placebo. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- English-speaking patients
- Patients 4 years of age up to 10 years of age
- Patients seen in the ED needing simple facial laceration repair
- Patients with no chronic medical problems
Key exclusion criteria (9 listed)
- Any patient who's parent or primary caretaker refuses consent
- Any patient who's parent or primary caretaker needs an interpreter
- Any child with complex laceration(s) or bites
- Any child who has received pain medication at home in response to the facial laceration.
- Children needing procedural sedation
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 |
|---|---|---|
| IbuprofenSubjects will receive topical LET and oral ibuprofen. | Drug | Ibuprofen |
| OxycodoneSubjects will receive topical LET and oral oxycodone. | Drug | Oxycodone |
| PlaceboSubjects will receive topical LET and oral placebo. | Other | Placebo |
Primary outcome
Pain scores
Time frame: At Triage, after first suture, and the worst during the procedure
The use of adjunctive oral analgesics for facial/scalp laceration repair decrease pain scores more effectively than LET alone.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen and Oxycodone in people with Laceration and Pain, run by Children's Hospitals and Clinics of Minnesota 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 4 inclusion and 9 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: paused, as of the sponsor's last update on 31 Jul 2013. 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?
Results are not available in the source record.
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?
Pain scores (time frame: At Triage, after first suture, and the worst during the procedure). 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 31 Jul 2013.