Laceration RepairPhase 2NCT03957304
Intranasal Dexmedetomidine Dose-finding Study
A Phase 2 study testing Dexmedetomidine in people with Laceration Repair, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The most common injury prompting an emergency department (ED) visit in children is a cut (laceration) that requires repair using stitches or skin glue. Despite anesthetic (freezing), laceration repair is often very distressful because in young children, most occur on the face. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Laceration Repair
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- 20 Feb 2020to 30 Mar 2022
- Phase
- Phase 2
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children age 1-10 years who present to the ED with an isolated laceration < 5 cm
- deemed to require suture repair based on the opinion of the treating physician
- predicted to resist positioning for laceration repair based on the opinion of the caregiver
Who cannot join
- laceration repair requiring procedural sedation (without IND) or local nerve block, - other injuries requiring reduction (fracture or dislocation) or repair (nailbed injury or laceration)
- lacerations containing foreign body material (including dirt and debris)
- history of hypersensitivity to dexmedetomidine
- occlusion of at least one nare due to mucus, polyps, septal deviation, etc.
- concomitant use of an alpha 2-adrenergic receptor agonist
- bradycardia or hypotension for age (possible transient but clinically insignificant adverse effects of dexmedetomidine)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intranasal Dexmedetomidine for Laceration Repair in Children: a Dose-finding Study
The most common injury prompting an emergency department (ED) visit in children is a cut (laceration) that requires repair using stitches or skin glue. Despite anesthetic (freezing), laceration repair is often very distressful because in young children, most occur on the face. There is currently no effective drug to relieve the distress of laceration repair in children. The goal is to find a safe and effective drug to reduce distress in children undergoing laceration repair. Dexmedetomidine is a new drug that safely provides mild sedation and can be given as a painless nasal spray. Intranasal dexmedetomidine (IND) has been shown to reduce distress in children undergoing painful procedures such as dental work and intravenous insertion. However, no large study has explored IND for laceration repair. In order for research to change the way we care for children, a large study that enrolls children across many paediatric EDs needs to be performed. The first step is to conduct a smaller study to identify the safest and most effective dose. The proposed study plans to enroll 55 children age 1-10 years who require laceration repair.
Read the detailed description
Design: This study will be designed as a phase II single-arm dose-escalation pilot study using the continual reassessment method.
Protocol: Sedation will be measured using the Pediatric Sedation State Scale (PSSS), an instrument validated for video scoring of children undergoing painful procedures. The PSSS is scored from 0 (dangerously sedated) to 5 (least sedated) easily by non-medical personnel and assesses over sedation and under sedation. Adequate sedation is a score of 2 or 3. Participants will be consecutively assigned to increasing doses of IND from 1-4 mcg/kg based on the continual reassessment method. Participants will be assigned to doses of IND from 1-4 mcg/kg, increasing in whole number increments. Initially three participants will receive 1mcg/kg and the number of participants at each dose of IND will be recorded. Data from these participants will be used to update a Bayesian model for the dose-response curve for all three categories of sedation. The following three participants will be assigned the dose with the highest posterior probability of an efficacy close to 0.8. This balances the need to determine the most efficacious dose but prevents an excessive number of over-sedations. For the Bayesian dose response model, a determination will be made as to the overall score category for each participant ("adequate", "over", or "under sedated" based on the PSSS). To be scored as "adequate", a participant must have a PSSS score of 2 or 3 for at least 90% of observations from initial positioning to tying of the last suture. If a participant does not retain a PSSS score of 2 or 3 for at least 90% of the observations, they will be categorized as either over or under-sedated, if the majority of the remaining PSSS scores are 0 or 1 or 4 or 5, respectively. Furthermore, if the participant remains awake, but not distressed during the procedure, they will be scored as a 2 based on the PSSS. However, for the purposes of the Bayesian dose response model, they will be scored as "under sedated" to avoid concluding that a lower dose of IND is effective based on the outcomes for participants that did not require sedation. Finally, participants who are noncompliant with IND will be categorized as an over-sedation as it is assumed that this dose was not well tolerated by the participant and dose escalation should be avoided. Data will be reviewed after each dose increment by a data safety monitoring board, who will confirm it is safe to escalate. Permissible co-interventions include topical and subcutaneous anesthetic, oral or IV analgesics, non-pharmacologic strategies for pain and distress.
Screening and Enrollment: Participants will be consecutively screened for eligibility during the hours of study recruitment.
Sample Size: This was calculated using the Bayesian continual reassessment method (20). Based on an adverse event rate of 10%, 4 dosing levels, an odds ratio for the effect size of 1.8, and a phase II trial accuracy level of 60%, an estimated a sample size of 55 participants was calculated.
- Conditions
- Laceration Repair
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intranasal dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine 1 mcg/kg | Experimental | Intranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 1 mcg/kg (max 100 mcg or 1 mL). Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 2 mcg/kg | Active comparator | Intranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 2 mcg/kg (max 100 mcg or 1 mL). Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 3 mcg/kg | Active comparator | Intranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 3 mcg/kg (max 100 mcg or 1 mL). Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 4 mcg/kg | Active comparator | Intranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 4 mcg/kg (max 100 mcg or 1 mL). Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate sedation
The number of participants with adequate sedation defined as a PSSS or 2 or 3 for the duration of the measurement period (initial positioning to tying of the last suture)
Measured: Index visit
Secondary outcomes (10)
Onset of sedation
Time to adequate sedation (based on PSSS score)
Measured: Index visit
Adverse effects
The number of participants with adverse effects based on the Quebec Guidelines for Reporting of Adverse Effects in Children
Measured: Index visit
Anxiolysis
Degree of anxiolysis as measured using the modified Yale Preoperative Anxiety Scale (mYPAS). The mYPAS is an observationale scale consisting of 22 items across 5 categories. The total score ranges from 0 to 100 with higher scores indicating greater anxiety.
Measured: Index visit
Compliance
Number of participants deemed a compliant with intervention administration
Measured: Index visit
Satisfaction with laceration repair: 5-item Likert scale
Satisfaction score using a 5-item Likert scale obtained from the caregiver, child (if > 7 years), individual performing the repair, and bedside nurse
Measured: Index visit
Nasal irritation
Score on the Faces Pain Scale - Revised (FPS-R) and obtained from children age > 4 years
Measured: Index visit
Length of stay
Duration of time from triage assessment to discharge time
Measured: Index visit
Consent rate
Proportion of eligible participants consented
Measured: Index visit
Delayed maladaptive behaviors
Proportion of children with delayed maladaptive behaviors measured with the Post-Hospital Behavior Questionnaire (PHBQ) assessed 24-48 hours post discharge. The PHBQ is comprised of 27 items among six subscales (general anxiety and regression, separation anxiety, eating disturbance, aggression toward authority, apathy/withdrawal, anxiety about sleep. For each item, parents are asked to compare their child's behavior before hospitalization to their current behavior (post-hospitalization) on a Likert-type scale using the following five response options: much less than before (1), less than before (2), same as before (3), more than before (4), and much more than before (5), producing a range from 27-135 with higher scores indicating greater severity of maladaptive behaviors.
Measured: 48 hours post-discharge
Wound complications
Number of participants with wound complications within 14 days of discharge (infection; dehiscence; contracture; retained suture material).
Measured: 14 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start20 Feb 2020
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laceration RepairStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose-escalation pilot study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957304
- Sponsor's protocol ID
- 51384
- Status last verified
- Apr 2021
- First submitted
- 17 May 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poonai N, Sabhaney V, Ali S, Stevens H, Bhatt M, Trottier ED, Brahmbhatt S, Coriolano K, Chapman A, Evans N, Mace C, Creene C, Meulendyks S, Heath A. Optimal Dose of Intranasal Dexmedetomidine for Laceration Repair in Children: A Phase II Dose-Ranging Study. Ann Emerg Med. 2023 Aug;82(2):179-190. doi: 10.1016/j.annemergmed.2023.01.023. Epub 2023 Mar 3.
PubMed 36870890
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine for Laceration Repair in Children: a Dose-finding Study
- ClinicalTrials.gov ID
- NCT03957304
- Acronym / sponsor ID
- 51384
- Conditions
- Laceration Repair
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 21 May 2019 (actual)
- 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.
The most common injury prompting an emergency department (ED) visit in children is a cut (laceration) that requires repair using stitches or skin glue. Despite anesthetic (freezing), laceration repair is often very distressful because in young children, most occur on the face. There is currently no effective drug to relieve the distress of laceration repair in children. The goal is to find a safe and effective drug to reduce distress in children undergoing laceration repair. Dexmedetomidine is a new drug that safely provides mild sedation and can be given as a painless nasal spray. Intranasal dexmedetomidine (IND) has been shown to reduce distress in children undergoing painful procedures such as dental work and intravenous insertion. However, no large study has explored IND for laceration repair. In order for research to change the way we care for children, a large study that enrolls children across many paediatric EDs needs to be performed. The first step is to conduct a smaller study to identify the safest and most effective dose. The proposed study plans to enroll 55 children age 1-10 years who require laceration repair.
Detailed description
Design: This study will be designed as a phase II single-arm dose-escalation pilot study using the continual reassessment method.
Protocol: Sedation will be measured using the Pediatric Sedation State Scale (PSSS), an instrument validated for video scoring of children undergoing painful procedures. The PSSS is scored from 0 (dangerously sedated) to 5 (least sedated) easily by non-medical personnel and assesses over sedation and under sedation. Adequate sedation is a score of 2 or 3. Participants will be consecutively assigned to increasing doses of IND from 1-4 mcg/kg based on the continual reassessment method. Participants will be assigned to doses of IND from 1-4 mcg/kg, increasing in whole number increments. Initially three participants will receive 1mcg/kg and the number of participants at each dose of IND will be recorded. Data from these participants will be used to update a Bayesian model for the dose-response curve for all three categories of sedation. The following three participants will be assigned the dose with the highest posterior probability of an efficacy close to 0.8. This balances the need to determine the most efficacious dose but prevents an excessive number of over-sedations. For the Bayesian dose response model, a determination will be made as to the overall score category for each participant ("adequate", "over", or "under sedated" based on the PSSS). To be scored as "adequate", a participant must have a PSSS score of 2 or 3 for at least 90% of observations from initial positioning to tying of the last suture. If a participant does not retain a PSSS score of 2 or 3 for at least 90% of the observations, they will be categorized as either over or under-sedated, if the majority of the remaining PSSS scores are 0 or 1 or 4 or 5, respectively. Furthermore, if the participant remains awake, but not distressed during the procedure, they will be scored as a 2 based on the PSSS. However, for the purposes of the Bayesian dose response model, they will be scored as "under sedated" to avoid concluding that a lower dose of IND is effective based on the outcomes for participants that did not require sedation. Finally, participants who are noncompliant with IND will be categorized as an over-sedation as it is assumed that this dose was not well tolerated by the participant and dose escalation should be avoided. Data will be reviewed after each dose increment by a data safety monitoring board, who will confirm it is safe to escalate. Permissible co-interventions include topical and subcutaneous anesthetic, oral or IV analgesics, non-pharmacologic strategies for pain and distress.
Screening and Enrollment: Participants will be consecutively screened for eligibility during the hours of study recruitment.
Sample Size: This was calculated using the Bayesian continual reassessment method (20). Based on an adverse event rate of 10%, 4 dosing levels, an odds ratio for the effect size of 1.8, and a phase II trial accuracy level of 60%, an estimated a sample size of 55 participants was calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Dose-escalation pilot study
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine 1 mcg/kg | Experimental | Drug: DexmedetomidineIntranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 1 mcg/kg (max 100 mcg or 1 mL). |
| Dexmedetomidine 2 mcg/kg | Active comparator | Drug: DexmedetomidineIntranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 2 mcg/kg (max 100 mcg or 1 mL). |
| Dexmedetomidine 3 mcg/kg | Active comparator | Drug: DexmedetomidineIntranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 3 mcg/kg (max 100 mcg or 1 mL). |
| Dexmedetomidine 4 mcg/kg | Active comparator | Drug: DexmedetomidineIntranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 4 mcg/kg (max 100 mcg or 1 mL). |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children age 1-10 years who present to the ED with an isolated laceration < 5 cm
- deemed to require suture repair based on the opinion of the treating physician
- predicted to resist positioning for laceration repair based on the opinion of the caregiver
Key exclusion criteria (6 listed)
- laceration repair requiring procedural sedation (without IND) or local nerve block, - other injuries requiring reduction (fracture or dislocation) or repair (nailbed injury or laceration)
- lacerations containing foreign body material (including dirt and debris)
- history of hypersensitivity to dexmedetomidine
- occlusion of at least one nare due to mucus, polyps, septal deviation, etc.
- concomitant use of an alpha 2-adrenergic receptor agonist
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 |
|---|---|---|
| DexmedetomidineIntranasal dexmedetomidine | Drug | Dexmedetomidine 1 mcg/kg, Dexmedetomidine 2 mcg/kg, Dexmedetomidine 3 mcg/kg, Dexmedetomidine 4 mcg/kg |
Primary outcome
Adequate sedation
Time frame: Index visit
The number of participants with adequate sedation defined as a PSSS or 2 or 3 for the duration of the measurement period (initial positioning to tying of the last suture)
10 secondary outcomes
Onset of sedation
Time frame: Index visit
Adverse effects
Time frame: Index visit
Anxiolysis
Time frame: Index visit
Compliance
Time frame: Index visit
Satisfaction with laceration repair: 5-item Likert scale
Time frame: Index visit
Nasal irritation
Time frame: Index visit
Length of stay
Time frame: Index visit
Consent rate
Time frame: Index visit
Delayed maladaptive behaviors
Time frame: 48 hours post-discharge
Wound complications
Time frame: 14 days post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 36870890Poonai N, Sabhaney V, Ali S, Stevens H, Bhatt M, Trottier ED, Brahmbhatt S, Coriolano K, Chapman A, Evans N, Mace C, Creene C, Meulendyks S, Heath A. Optimal Dose of Intranasal Dexmedetomidine for Laceration Repair in Children: A Phase II Dose-Ranging Study. Ann Emerg Med. 2023 Aug;82(2):179-190. doi: 10.1016/j.annemergmed.2023.01.023. Epub 2023 Mar 3.
- Individual participant dataSharing planned: No
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 Phase 2 study testing Dexmedetomidine in people with Laceration Repair, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 6 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 7 Apr 2022. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adequate sedation (time frame: Index visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03957304, which also lists 1 linked publication.
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 7 Apr 2022; AzTrials last refreshed its copy on 1 Nov 2026.