Intranasal Ketamine for Procedural Sedation

NCT02828566 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: 106550
• Study Type: interventional
• Target: 470
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will examine the effectiveness of intranasal (IN) ketamine compared to standard intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in the paediatric population. The aim is to assess if IN administration is equivalent to the current standard of care, IV. The population to be studied is children 4-17 years of age who require a simple orthopaedic reduction. Following a double dummy approach to overcome the difficulty in masking interventions, each participant will receive both IV and IN interventions, only one of which will be the real drug. Procedural sedation and analgesia (PSA) will be assessed using the Dartmouth Operative Conditions Scale (DOCS).

Conditions

Bone Fractures; Dislocations

Outcome Measures

Primary Outcomes (1)

• Adequacy of sedation

  Proportion with DOCS score -2 to +2 for duration of fracture reduction

  Duration of fracture reduction

Secondary Outcomes (21)

• Depth of sedation

  Duration of fracture reduction

• Onset of adequate sedation

  Within 1 hour following intervention

• Duration of sedation

  Within 2 hours following intervention

• Proportion of time participant adequately sedated during fracture reduction

  Within 2 hours following intervention

• Adverse events

  Within 2 hours following intervention

Study Arms (2)

IN ketamine and IV saline

EXPERIMENTAL

Ketamine, single dose, 10 mg/kg (0.1 mL/kg) of 100 mg/mL solution delivered intranasally using an atomizer and divided to both nares to a maximum of 800 mg (8 mL) AND 0.9% normal saline (NS) 0.02 to 0.03 mL/kg delivered intravenously to a maximum of 2.4 mL

Drug: IN ketamine; Drug: IV saline 0.9%

IV ketamine and IN saline

ACTIVE COMPARATOR

Ketamine, single dose, 1 to 1.5 mg/kg (0.02 to 0.03 mL/kg) of 50 mg/mL solution delivered intravenously, to a maximum of 120 mg (2.4 mL) AND 0.9% normal saline (NS) 0.1 mL/kg delivered intranasally using an atomizer and divided to both nares, to a maximum of 8 mL

Drug: IV ketamine; Drug: IN saline 0.9%

Interventions

IN ketamine DRUG

Intranasal ketamine 100 mg/mL solution (10 mg/kg, maximum 800 mg)

Also known as: ketamine hydrochloride

IN ketamine and IV saline

IV ketamine DRUG

Intravenous ketamine 50 mg/mL solution (1 to 1.5 mg/kg, maximum 120 mg)

Also known as: ketamine hydrochloride

IV ketamine and IN saline

IN saline 0.9% DRUG

Intranasal 0.9% normal saline

IV ketamine and IN saline

IV saline 0.9% DRUG

Intravenous 0.9% normal saline

IN ketamine and IV saline

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 4 -17 years
• Up to 80 kg
• Presenting the paediatric emergency department
• Require a closed reduction by procedural sedation and analgesia
• Acute (=\< 48 hours) distal radius and/or ulna fracture that is angulated with or without displacement
• No more than 0.5 cm shortening in either the radius or ulna (not both)

You may not qualify if:

• Previous hypersensitivity reaction to ketamine
• Globe rupture
• Traumatic brain injury with intracranial hemorrhage
• History of uncontrolled hypertension
• Nasal bone deformity
• Duration of reduction expected to be greater than 20 minutes
• Poor English or French fluency in the absence of a native language interpreter
• American Society of Anesthesiologists (ASA) class of 3 or greater
• Previous sedation with ketamine within 24 hours
• Previous diagnosis of schizophrenia or psychosis based on DSM-V criteria
• Pregnancy
• Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction
• Multi-limb trauma
• Hemodynamic compromise
• Glasgow coma score \< 15

Sponsors & Collaborators

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

Related Publications (1)

• Heath A, Offringa M, Pechlivanoglou P, Rios JD, Klassen TP, Poonai N, Pullenayegum E; KidsCAN PERC Innovative Paediatric Clinical Trials Team. Determining a Bayesian predictive power stopping rule for futility in a non-inferiority trial with binary outcomes. Contemp Clin Trials Commun. 2020 Apr 8;18:100561. doi: 10.1016/j.conctc.2020.100561. eCollection 2020 Jun.

  PMID: 32300671 DERIVED

MeSH Terms

Conditions

Fractures, Bone; Joint Dislocations

Interventions

Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Naveen Poonai, MD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naveen Poonai, MD

CONTACT

5196858500; naveen.poonai@lhsc.on.ca

Cindy Langford, RN

CONTACT

5196858500; cindy.langford@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 11, 2016
• Study Start: October 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2019
• Last Updated: August 29, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share