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NMDA Receptor Antagonist
Intranasal Ketamine + Dexmedetomidine for Procedural Sedation (Ketodex Trial)
Phase 2 & 3
Recruiting
Led By Naveen Poonai, MD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Dislocation of a shoulder or elbow
Painful procedure including one of the following:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion in the ed and up to 72 hours post-discharge
Awards & highlights
Ketodex Trial Summary
This trial is testing if a ketamine and dexmedetomidine mix given through the nose is non-inferior to ketamine given intravenously for depth of sedation in children during a closed reduction procedure.
Who is the study for?
This trial is for children aged 4-17 with orthopedic injuries like forearm fractures or dislocations needing sedation, weighing up to 60 kg. They must be able to follow the study's procedures and have no severe health issues like heart disease, uncontrolled hypertension, or cognitive impairments that prevent consent.Check my eligibility
What is being tested?
The trial tests intranasal dexmedetomidine plus ketamine (IN Ketodex) against IV ketamine for sedation in kids during bone setting. It aims to see if IN Ketodex can provide deep enough sedation without the pain of an IV line.See study design
What are the potential side effects?
Possible side effects include nasal discomfort from the spray, drowsiness, changes in blood pressure or heart rate, mood changes, nausea or vomiting. Rarely there could be allergic reactions such as rash or breathing difficulties.
Ketodex Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a dislocated shoulder or elbow.
Select...
I am undergoing a painful medical procedure.
Select...
I weigh 60 kg or less.
Select...
My child is between 4 and 17 years old.
Select...
Both of my nostrils are clear and not blocked.
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I have a broken bone in my hand or finger.
Select...
I have a broken forearm.
Select...
I have a Type II fracture above my elbow.
Ketodex Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion in the ed and up to 72 hours post-discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion in the ed and up to 72 hours post-discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adequate sedation
Secondary outcome measures
Adverse effects
Length of stay
Time to wakening
Other outcome measures
Adjunctive IV therapy and medications
Caregiver, participant, bedside nurse or respiratory therapist, and physician satisfaction
Duration of procedure
+6 moreKetodex Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: IN Ketodex (D4K2)Experimental Treatment1 Intervention
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
Group II: IN Ketodex (D3K3)Experimental Treatment1 Intervention
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
Group III: IN Ketodex (D2K4)Experimental Treatment1 Intervention
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
Group IV: IV KetamineActive Control1 Intervention
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
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Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
658 Previous Clinical Trials
413,258 Total Patients Enrolled
Naveen PoonaiLead Sponsor
2 Previous Clinical Trials
433 Total Patients Enrolled
Naveen Poonai, MDPrincipal InvestigatorWestern University
5 Previous Clinical Trials
1,253 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have obstructive sleep apnea.Your doctor has determined that your heart or blood pressure is not stable.I have had a hematoma block in the last 24 hours.You have a score less than 15 on the Glasgow Coma Scale, which measures your level of consciousness.I have had a dislocated shoulder or elbow.Your fracture is not severe or very short.I have kidney problems.I am undergoing a painful medical procedure.I have a nasal bone deformity or a deviated septum.I am expected to need only one dose of IV sedation for my procedure.I weigh 60 kg or less.I am able to understand information, make decisions, and express my pain and satisfaction.I have a heart condition from birth or an irregular heartbeat.I have liver problems.My child is between 4 and 17 years old.You have had a bad allergic reaction to ketamine or dexmedetomidine in the past, which caused symptoms like rash, difficulty breathing, low blood pressure, stopped breathing, or tightening of the throat muscles.I have a brain injury with bleeding inside my skull.My fracture is shattered or comes with a joint dislocation.Both of my nostrils are clear and not blocked.I have an untreated hormone imbalance.I might have a ruptured eyeball.My doctor says I need sedation for a procedure.I have a broken bone in my hand or finger.I have a broken forearm.I have had more than one bone fracture or dislocation that needed to be fixed.I have not had ketamine or a hematoma block in the last 24 hours.My blood pressure is not well-controlled.I have a Type II fracture above my elbow.
Research Study Groups:
This trial has the following groups:- Group 1: IN Ketodex (D4K2)
- Group 2: IN Ketodex (D3K3)
- Group 3: IN Ketodex (D2K4)
- Group 4: IV Ketamine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How is IN Ketodex (D4K2) commonly employed?
"D4K2, marketed as Ketodex, is most often used in relation to general anesthesia. It has also been indicated for use cases like anesthesia procedures, disease, and ventilations, mechanical."
Answered by AI
What other research has been published about IN Ketodex (D4K2)?
"The first documented study of IN Ketodex (D4K2) was in 2011 at Meilahti Hospital. Since then, a total of 961 clinical trials have been completed with 217 active studies currently being conducted. A large number of these Active trials are based out of London and Alberta."
Answered by AI
Can adults participate in this clinical trial?
"According to the parameters set out by the researchers, children aged 4 to 17 qualify for this particular trial. There are a total of 134 trials recruiting participants under 18 and 474 trials with an age limit of 65+."
Answered by AI
Is this clinical trial taking place at many hospitals throughout the United States?
"Currently, there are 5 trial sites recruiting patients with additional locations in London, Edmonton and Hamilton. It may be advantageous to select the clinical trial site nearest you to reduce travel time obligations."
Answered by AI
Are there any slots left for patients who want to join this experiment?
"This study, which was originally posted on March 11th 2020, is currently looking for participants. The most recent update to the listing was made on July 25th 2022."
Answered by AI
What are the requirements for participation in this trial?
"This study is for 400 children and adolescents aged 4-17 with fractures."
Answered by AI
Are there any caps on the number of participants for this research project?
"That is correct. The clinical trial, as indicated by the information available on clinicaltrials.gov, is still recruiting participants. It was first posted on March 11th 2020 and has since been edited July 25th of this year. They are looking for 400 individuals to participate at 5 different sites."
Answered by AI
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