INK Feasibility Study

NCT05783492 | Withdrawn Phase 3

• 1 other identifier: 113103
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Procedural Sedation

Keywords

ketamine

Outcome Measures

Primary Outcomes (1)

• Adequacy of sedation

  Dartmouth Operative Conditions Scale (DOCS) score between -2 and +2 for the duration of the closed reduction AND, (ii) No additional IV ketamine is given during closed reduction for the purpose of sedation, AND (iii) The patient did not actively resist, cry, or require physical restraint for completion of the closed reduction.

  1 hour

Secondary Outcomes (4)

• Length of stay

  1 hour

• Onset of sedation

  1 hour

• Duration of sedation

  1 hour

• Adverse effects

  1 hour

Study Arms (1)

Intranasal ketamine

EXPERIMENTAL

Intranasal ketamine 10 mg/kg

Drug: Intranasal ketamine

Interventions

Intranasal ketamine DRUG

10 mg/kg single dose in 0.5 mL sprays in each nare separated by 60 seconds

Intranasal ketamine

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• General Criteria
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Deemed by treating physician to require procedural sedation using ketamine Specific Criteria
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• Children presenting to the paediatric EDs of participating sites age 7-17 years
• Weighing up to and including 80 kg
• Distal radius +/- ulna fracture or dislocation of a shoulder, elbow, patella, or digit
• Closed reduction expected to take no more than 5 minutes to reduce (as determined by the procedure physician and not including cast or splint application).

You may not qualify if:

• \) Previous hypersensitivity reaction to ketamine including rash, difficulty breathing, hypotension, apnea, or laryngospasm; 2) Suspected globe rupture; 3) Concomitant traumatic brain injury with intracranial hemorrhage; 4) Uncontrolled hypertension; 5) Nasal bone deformity or nasal obstruction with at least one nare obstructed due to allergic or viral rhinitis, sinusitis, nasal polyps, or septal deviation; 6) Poor English or French fluency in the absence of native language interpreter; 7) American Society of Anesthesiologists (ASA) class 3 or greater; 8) Previous diagnosis of schizophrenia or active psychosis as per the treating physician 9) Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction; 10) Multi-limb trauma; 11) Hemodynamic compromise as per the treating physician; 12) Glasgow coma score \< 15; 13) Previous sedation with ketamine within 24 hours; 14) Fracture is comminuted or associated with a dislocation; 15) Participant has undergone a hematoma block within 24 hours; 16) Isolated ulna fracture; 17) Previous enrollment in the trial; 18) Suspected pregnancy

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intranasal ketamine 10 mg/kg single dose

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: March 24, 2023
• Study Start: January 1, 2024
• Primary Completion: March 31, 2024
• Study Completion: April 30, 2024
• Last Updated: March 24, 2023

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share