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NCT05783492
INK Feasibility Study
Phase 3 trial testing Intranasal ketamine in Procedural Sedation. Withdrawn.
31 March 2024
Quick facts
| Lead sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Start date | 1 January 2024 |
| Primary completion | 31 March 2024 |
| Estimated completion | 30 April 2024 |
Drugs / interventions tested
- Intranasal ketamine — full drug profile →
Conditions studied
- Procedural Sedation — all drugs for Procedural Sedation →
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Who can join
Adults 7 to 17, any sex, with Procedural Sedation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The trial (Intranasal ketamine for procedural sedation in children: a randomized controlled non-inferiority multicenter trial or INK; ReDA 5496; CTO 1545) is being scheduled for launch in Spring 2019. Due to the possibility of failure of the experimental intervention (intranasal ketamine 10 mg/kg), the data safety monitoring board (DSMB) and statistical methods team would like to explore the possibility of developing a stopping rule to prevent patients from being enrolled in a futile trial and conserve resources. In order to get accurate data to develop a statistically robust stopping rule, it is necessary to conduct a cohort study of patients that receive the INK trial's experimental intervention and according to it's protocol. This cohort study will help estimate the chance of adequate sedation and inform the final dosing protocol for the INK trial.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05783492
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Intranasal ketamine
Trials testing the same drug.
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- NCT07305883 — Comparison of Intranasal Ketorolac and Intranasal Ketamine in Digital Nerve Block Pain · Phase 3 · not yet recruiting
- NCT07055828 — Nebulized vs. IV Ketamine in Preventing Shivering Post Spinal Anesthesia · NA · active not recruiting
- NCT04150757 — Intranasal Ketamine for Pain Control in Patients with Sickle Cell Disease and Vaso-occlusive Episode (VOE) in the PED · Phase 3 · terminated
- NCT03539887 — Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse · Phase 3 · completed
Other recruiting trials for Procedural Sedation
Currently open trials in the same condition.
- NCT07213544 — Remimazolam vs Propofol in Laser Burn Cases · Phase 4 · recruiting
- NCT07336628 — Propofol vs Remifentanil for Sedation in Gastroscopy · NA · active not recruiting
- NCT06414395 — The Effects of Different Loading Doses of Dexmedetomidine on The Bispectral Index-Guided Propofol Sedation in Patients U · Phase 4 · recruiting
Other London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's trials
Trials by the same sponsor.
- NCT07588711 — Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Neuropathic Pain Following Spinal Cord Injury · NA · not yet recruiting
- NCT07585292 — Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Musculoskeletal Pain in Cerebral Palsy · NA · not yet recruiting
- NCT07510906 — Evaluation of a Prostate-Targeted PET Imaging System (P-PET) for Detecting Prostate Cancer · NA · not yet recruiting
- NCT03166072 — Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers · NA · not yet recruiting
- NCT06035809 — Sensory Motor Arousal Regulation Treatment (SMART) Study · NA · not yet recruiting
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 NCT05783492 (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: 24 March 2023
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/NCT05783492.
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