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NCT03957304
Intranasal Dexmedetomidine Dose-finding Study
Phase 2 trial testing Dexmedetomidine in Laceration Repair in 55 participants. Completed in 30 March 2022.
30 March 2022
Quick facts
| Lead sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 20 February 2020 |
| Primary completion | 30 March 2022 |
| Estimated completion | 30 March 2022 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Dexmedetomidine (dexmedetomidine) — full drug profile →
Conditions studied
- Laceration Repair — all drugs for Laceration Repair →
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Who can join
Adults 1 to 10, any sex, with Laceration Repair. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03957304
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
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Trials testing the same drug.
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- NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting
Other London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03957304 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Last refreshed: 7 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03957304.
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