What side effects are associated with this type of intervention?

The most common treatments for dislocated joints, particularly those involving intranasal dexmedetomidine plus ketamine (IN Ketodex), can have several side effects. Dexmedetomidine may cause hypotension, bradycardia, and dry mouth, while ketamine can lead to psychomimetic effects such as hallucinations, increased intracranial and intraocular pressure, and cardiovascular effects like hypertension and tachycardia. Combining these agents requires careful monitoring to manage and mitigate these potential adverse effects.

What prior FDA approvals exist?

The FDA has approved various treatments for dislocated joints that involve sedation and analgesia. While specific combinations like intranasal dexmedetomidine and ketamine (IN Ketodex) are still under investigation, both dexmedetomidine and ketamine have been approved for other uses. Dexmedetomidine, an alpha-2 adrenergic agonist, is approved for sedation in intensive care settings and procedural sedation. Ketamine, an NMDA receptor antagonist, is approved for anesthesia and pain management. These drugs provide effective sedation and analgesia, which are crucial for the reduction of dislocated joints, although their combined intranasal use for this specific indication is still being studied.

What other types of research exist?

Promising, novel alternatives to IN Ketodex for treating dislocated joint patients include intranasal fentanyl and intranasal dihydroergotamine. Intranasal fentanyl is effective for acute pain management, while intranasal dihydroergotamine has shown efficacy in treating acute migraine symptoms and could be beneficial for acute pain relief in dislocated joints.

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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:

Must not have

Obstructive sleep apnea

Participant has undergone a hematoma block within 24 hours;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion in the ed and up to 72 hours post-discharge

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new way to help children with broken bones feel less pain during treatment. Instead of using a painful method, doctors will give a mix of two medications through the nose. This method aims to make the experience less distressing and more comfortable for children.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a dislocated shoulder or elbow.

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I am undergoing a painful medical procedure.

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I weigh 60 kg or less.

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My child is between 4 and 17 years old.

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Both of my nostrils are clear and not blocked.

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I have a broken bone in my hand or finger.

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I have a broken forearm.

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I have a Type II fracture above my elbow.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have obstructive sleep apnea.

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I have had a hematoma block in the last 24 hours.

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I have kidney problems.

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I have a nasal bone deformity or a deviated septum.

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I am able to understand information, make decisions, and express my pain and satisfaction.

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I have a heart condition from birth or an irregular heartbeat.

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I have liver problems.

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I have a brain injury with bleeding inside my skull.

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My fracture is shattered or comes with a joint dislocation.

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I have an untreated hormone imbalance.

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I might have a ruptured eyeball.

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I have had more than one bone fracture or dislocation that needed to be fixed.

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My blood pressure is not well-controlled.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion in the ed and up to 72 hours post-discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adequate sedation

Secondary study objectives

Adverse effects

Length of stay

Time to wakening

Other study objectives

Adjunctive IV therapy and medications

Caregiver, participant, bedside nurse or respiratory therapist, and physician satisfaction

Duration of procedure

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for dislocated joints often involve pharmacological agents that provide both sedation and analgesia. Dexmedetomidine, an alpha-2 adrenergic agonist, works by inhibiting norepinephrine release, thereby reducing sympathetic activity and pain perception. Ketamine, an NMDA receptor antagonist, offers dissociative anesthesia and analgesia by blocking glutamate, a neurotransmitter involved in pain transmission. These mechanisms are essential for dislocated joint patients as they ensure effective pain relief and sedation during procedures like closed reduction, minimizing distress and improving patient outcomes.

Medetomidine--ketamine--diazepam anesthesia in the rabbit.Comparison of intrathecal versus intra-articular dexmedetomidine as an adjuvant to bupivacaine on postoperative pain following knee arthroscopy: a randomized clinical trial.Comparison of meperidine plus midazolam and fentanyl plus midazolam in procedural sedation: a double-blind, randomized controlled trial.