- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04195256
Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation (Ketodex)
Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation in Children: an Adaptive Randomized Controlled Non-inferiority Multicenter Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Naveen Poonai, MD
- Phone Number: 5196858500
- Email: naveen.poonai@lhsc.on.ca
Study Contact Backup
- Name: Kamary Coriolano, PhD
- Phone Number: 5196858500
- Email: Kamary.CoriolanoDaSilva@lhsc.on.ca
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada
- Recruiting
- Stollery Children's Hospital
-
Contact:
- Samina Ali, MBBS
-
Sub-Investigator:
- Samina Ali, MBBS
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- Active, not recruiting
- BC Children's Hospital
-
-
Ontario
-
Hamilton, Ontario, Canada
- Recruiting
- McMaster Children's Hospital
-
Contact:
- April Kam, MD
-
Sub-Investigator:
- April Kam, MD
-
London, Ontario, Canada, N6A5W9
- Recruiting
- London Health Sciences Centre
-
Contact:
- Naveen Poonai, MD
- Phone Number: 5196945309
- Email: naveen.poonai@lhsc.on.ca
-
Ottawa, Ontario, Canada
- Not yet recruiting
- Children's Hospital of Eastern Ontario
-
Contact:
- Maala Bhatt, MD
-
Sub-Investigator:
- Maala Bhatt, MD
-
Winnipeg, Ontario, Canada
- Recruiting
- Winnipeg Children'S Hospital
-
Contact:
- Darcy Beer, MD
- Email: darcy.beer@umanitoba.ca
-
Sub-Investigator:
- Darcy Beer, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA
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
Specific criteria
- Children presenting to the paediatric EDs of participating sites age 4-17 years
- Weighing up to and including 60 kg
Painful procedure including one of the following:
- Forearm fracture
- Metacarpal or phalangeal fracture
- Dislocation of a shoulder or elbow
- Type II supracondylar fracture
- Closed reduction expected to not require more than one dose of IV sedative sedation medication (as determined by the procedure physician and not including cast or splint application).
- Both nares are fully patent.
- Fracture is minimally or not shortened
EXCLUSION CRITERIA
- Previous hypersensitivity reaction to ketamine or dexmedetomidine including rash, difficulty breathing, hypotension, apnea, or laryngospasm;
- Suspected globe rupture;
- Concomitant traumatic brain injury with intracranial hemorrhage;
- Uncontrolled hypertension;
- Nasal bone deformity or septal deviation;
- Poor English or French fluency in the absence of native language interpreter;
- American Society of Anesthesiologists (ASA) class 3 or greater;
- Previous diagnosis of schizophrenia or active psychosis as per the treating physician
- Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction;
- More than one fracture or dislocation requiring reduction;
- Hemodynamic compromise as per the treating physician;
- Glasgow coma score < 15;
- Previous sedation with ketamine or hematoma block within 24 hours;
- Fracture is comminuted or associated with a dislocation;
- Participant has undergone a hematoma block within 24 hours;
- Obstructive sleep apnea
- Previous enrollment in the trial;
- Suspected pregnancy
- Congenital heart disease or known cardiac dysrhythmia
- Known or suspected hepatic impairment
- Known renal insufficiency
- Uncorrected mineralocorticoid deficiency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IN Ketodex (D4K2)
Dexmedetomidine (Pfizer, Kirkland, Quebec), single-dose, 4 mcg/kg (0.04 mL/kg) of 100 mcg/mL solution, maximum of 200 mcg (2 mL) THEN Ketamine (Sandoz, Mississauga, Ontario), single dose, 2 mg/kg (0.04 mL/kg) of 50 mg/mL solution, maximum of 200 mg (4 mL) (D4K2), both delivered intranasally using a mucosal atomizer device (MAD) and divided to both nares AND 0.9% normal saline 0.03 mL/kg delivered intravenously to a maximum of 2 mL
|
Dexmedetomidine (Pfizer, Kirkland, Quebec), single-dose, 4 mcg/kg (0.04 mL/kg) of 100 mcg/mL solution, maximum of 200 mcg (2 mL) THEN Ketamine (Sandoz, Mississauga, Ontario), single dose, 2 mg/kg (0.04 mL/kg) of 50 mg/mL solution, maximum of 200 mg (4 mL) (D4K2), both delivered intranasally using a mucosal atomizer device (MAD) and divided to both nares AND 0.9% normal saline 0.03 mL/kg delivered intravenously to a maximum of 2 mL
Other Names:
|
Experimental: IN Ketodex (D3K3)
Dexmedetomidine (Pfizer, Kirkland, Quebec), single-dose, 3 mcg/kg (0.03 mL/kg) of 100 mcg/mL solution, maximum of 200 mcg (2 mL) THEN Ketamine (Sandoz, Mississauga, Ontario), single dose, 3 mg/kg (0.06 mL/kg) of 50 mg/mL solution, maximum of 300 mg (6 mL) (D3K3), both delivered intranasally using a mucosal atomizer device (MAD) and divided to both nares AND 0.9% normal saline 0.03 mL/kg delivered intravenously to a maximum of 2 mL
|
Dexmedetomidine (Pfizer, Kirkland, Quebec), single-dose, 3 mcg/kg (0.03 mL/kg) of 100 mcg/mL solution, maximum of 200 mcg (2 mL) THEN Ketamine (Sandoz, Mississauga, Ontario), single dose, 3 mg/kg (0.06 mL/kg) of 50 mg/mL solution, maximum of 300 mg (6 mL) (D3K3), both delivered intranasally using a mucosal atomizer device (MAD) and divided to both nares AND 0.9% normal saline 0.03 mL/kg delivered intravenously to a maximum of 2 mL
Other Names:
|
Experimental: IN Ketodex (D2K4)
Dexmedetomidine (Pfizer, Kirkland, Quebec), single-dose, 2 mcg/kg (0.02 mL/kg) of 100 mcg/mL solution, maximum of 200 mcg (2 mL) THEN Ketamine (Sandoz, Mississauga, Ontario), single dose, 4 mg/kg (0.08 mL/kg) of 50 mg/mL solution, maximum of 400 mg (8 mL) (D2K4), both delivered intranasally using a mucosal atomizer device (MAD) and divided to both nares AND 0.9% normal saline 0.03 mL/kg delivered intravenously to a maximum of 2 mL
|
Dexmedetomidine (Pfizer, Kirkland, Quebec), single-dose, 2 mcg/kg (0.02 mL/kg) of 100 mcg/mL solution, maximum of 200 mcg (2 mL) THEN Ketamine (Sandoz, Mississauga, Ontario), single dose, 4 mg/kg (0.08 mL/kg) of 50 mg/mL solution, maximum of 400 mg (8 mL) (D2K4), both delivered intranasally using a mucosal atomizer device (MAD) and divided to both nares AND 0.9% normal saline 0.03 mL/kg delivered intravenously to a maximum of 2 mL
Other Names:
|
Active Comparator: IV Ketamine
Ketamine, single dose, 1.5 mg/kg (0.03 mL/kg) of 50 mg/mL solution delivered intravenously, to a maximum of 100 mg (2 mL) AND two aliquots of 0.9% normal saline in 3 possible combinations: (i) 0.04 mL/kg (max 2 mL) then 0.04 mL/kg (max 4 mL) (placebo D4K2), (ii) 0.03 mL/kg (max 2 mL) then 0.06 mL/kg (max 6 mL) (placebo D3K3), (iii) 0.02 mL/kg (max 2 mL) then 0.08 mL/kg (max 8 mL) (placebo D2K4), delivered intranasally using a MAD and divided to both nares
|
Ketamine, single dose, 1.5 mg/kg (0.03 mL/kg) of 50 mg/mL solution delivered intravenously, to a maximum of 100 mg (2 mL) AND two aliquots of 0.9% normal saline in 3 possible combinations: (i) 0.04 mL/kg (max 2 mL) then 0.04 mL/kg (max 4 mL) (placebo D4K2), (ii) 0.03 mL/kg (max 2 mL) then 0.06 mL/kg (max 6 mL) (placebo D3K3), (iii) 0.02 mL/kg (max 2 mL) then 0.08 mL/kg (max 8 mL) (placebo D2K4), delivered intranasally using a MAD and divided to both nares
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adequate sedation
Time Frame: Through study completion in the ED (4 hours)
|
Adequate is defined as fulfillment of all three of the following criteria: (i) A Pediatric Sedation State Scale (PSSS) score of 2 or 3 for the duration of the procedure (defined for closed reduction as the interval of time from the first application of traction or manipulation of the injured limb for the purpose of anatomical realignment to the last application of a realigning force). The PSSS is scored from 0 to 5 in discrete integer values every 15 seconds. A score of 4 or 5 indicates under-sedation and a score of 0 or 1 indicates over sedation. (ii) No additional medication is given during the procedure for the purpose of sedation. (iii) The patient did not actively resist, cry, or require physical restraint for completion of the closed reduction. |
Through study completion in the ED (4 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay
Time Frame: Through study completion in the ED (4 hours)
|
Defined as the time recorded in the medical record between triage and discharge.
|
Through study completion in the ED (4 hours)
|
Time to wakening
Time Frame: Through study completion in the ED (4 hours)
|
This will be defined as the duration of time between the first pair of IN sprays and the first PSSS score of > 3 post-closed reduction.
|
Through study completion in the ED (4 hours)
|
Adverse effects
Time Frame: Through study completion in the ED and up to 72 hours post-discharge
|
Adverse effects as defined by Health Canada reporting standards
|
Through study completion in the ED and up to 72 hours post-discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay due to procedural sedation
Time Frame: Through study completion in the ED (4 hours)
|
Defined as the time interval from the first pair of IN sprays/IV dose to discharge, reflective of the time difference associated with different routes of administration.
|
Through study completion in the ED (4 hours)
|
Duration of procedure
Time Frame: Through study completion in the ED (4 hours)
|
Defined as time of the first pair of IN sprays to the end of cast or splint application (closed reduction) in minutes
|
Through study completion in the ED (4 hours)
|
Caregiver, participant, bedside nurse or respiratory therapist, and physician satisfaction
Time Frame: Through study completion in the ED (4 hours)
|
Satisfaction will be measured using a visual analog scale (VAS) when the participant is deemed ready for discharge.
The following questions will be posed: How satisfied were you with your child's sedation?
(Caregiver if at bedside), How happy were you with your sleep?
(Participant), or How satisfied were you with the level of sedation in your patient?
(Sedating physician & nurse/respiratory therapist as per who is at bedside).
|
Through study completion in the ED (4 hours)
|
Nasal irritation
Time Frame: Through study completion in the ED (4 hours)
|
Discomfort associated with nasal sprays will be assessed by the research nurse using the Faces Pain Scale -Revised (FPS-R) when the participant is deemed ready for discharge.
The FPS-R is a self-report measure scored as either 0,2,4,6,8,10, with increasing numbers indicating greater pain.
|
Through study completion in the ED (4 hours)
|
Volume of IN intervention received / Volume of IN intervention intended
Time Frame: Through study completion in the ED (4 hours)
|
Volume of IN intervention received / Volume of IN intervention intended
|
Through study completion in the ED (4 hours)
|
Adjunctive IV therapy and medications
Time Frame: Through study completion in the ED (4 hours)
|
The number of participants requiring an IV for therapy unrelated to sedation (eg.
analgesics, antibiotics, antiemetics, fluids) will be recorded.
|
Through study completion in the ED (4 hours)
|
Pre-sedation Pain
Time Frame: Through study completion in the ED (4 hours)
|
Will be recorded by the research nurse from the participant using the Faces Pain Scale - Revised (FPS-R) immediately prior to the first pair of intranasal sprays
|
Through study completion in the ED (4 hours)
|
Patient Preference
Time Frame: Through study completion in the ED (4 hours)
|
The following question will be posed to the child: "If you were to be put to sleep again for an injury, what would you prefer, an intravenous needle or nasal sprays (choose one)?"
|
Through study completion in the ED (4 hours)
|
Exploratory subgroup analyses
Time Frame: Through study completion in the ED (4 hours)
|
A planned subgroup analyses to determine whether the between group difference in adequacy of sedation is dependent on (i) pain score prior to sedation.
|
Through study completion in the ED (4 hours)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Naveen Poonai, MD, Western University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Joint Diseases
- Musculoskeletal Diseases
- Joint Dislocations
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Ketamine
- Dexmedetomidine
Other Study ID Numbers
- 091819
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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