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History of Changes for Study: NCT02402868
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children
Latest version (submitted August 11, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 27, 2015 None (earliest Version on record)
2 March 2, 2016 Recruitment Status, Study Status, Contacts/Locations, Arms and Interventions and Oversight
3 May 26, 2016 Recruitment Status, Study Status, Outcome Measures, Eligibility, Contacts/Locations, Study Design and Study Description
4 June 1, 2016 Recruitment Status, Outcome Measures, Study Status, IPDSharing, Contacts/Locations, Eligibility and Arms and Interventions
5 June 9, 2016 Eligibility, Outcome Measures, Arms and Interventions, Study Description and Study Status
6 August 11, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT02402868
Submitted Date:  March 27, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: 106549
Brief Title: Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children
Official Title: Intranasal Ketamine Versus Intravenous Ketamine for Procedural Conscious Sedation in Children: a Multi-centre Randomized Controlled Non-inferiority Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2015
Overall Status: Not yet recruiting
Study Start: August 2015
Primary Completion: September 2017 [Anticipated]
Study Completion: December 2017 [Anticipated]
First Submitted: March 25, 2015
First Submitted that
Met QC Criteria:
March 27, 2015
First Posted: March 30, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 27, 2015
Last Update Posted: March 30, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Lawson Health Research Institute
Responsible Party: Principal Investigator
Investigator: Naveen Poonai
Official Title: Principal Investigator
Affiliation: Lawson Health Research Institute
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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 5-17 years of age who require a simple orthopaedic reduction. Following a double dummy approach to overcome the difficulty in masking interventions, each participant will recieve both IV and IN interventions, only one of which will be the real drug. Procedural conscious sedation (PCS) will be assessed using the University of Michigan Sedation Scale (UMSS).
Detailed Description: Randomization and concealment of allocation will be pharmacy-controlled using a computer-based random number generator. The treating physician, research assistant, and participant will be blinded to the intervention. Eligible participants will be randomized in a 1:1 allocation ratio with a stratified block design of six to either (1) IN ketamine (each single dose, 5 mg/kg prepared in 0.9% NS in 3 mL syringe and atomizer, to a maximum of 1.5 mL) PLUS IV 0.9% NS 5 mL or (2) IV ketamine (single dose, 1 mg/kg, to a maximum 100 mg) PLUS intranasal 0.9% NS 1.5 mL divided to both nares. Due to the perceptible differences in interventional routes, each participant will receive both IV and IN interventions using this double-dummy approach. For IN dose volumes less than or equal to 0.5 mL, the entire dose will be delivered into 1 nostril and for doses greater than 0.5 mL, the dose will be divided equally between both nares. Adjuctive sedation will be given as needed in the form of IV ketamine, 1 mg/kg every 10 minutes for participants who do not achieve adequate sedation at 20 minutes (UMSS score of 2 or greater). A figure of the atomizer device used to deliver the IN agent has been uploaded. Additionally, each participant will receive a single intranasal spray of 1% lidocaine gel because there are some reports of mild, transient intranasal discomfort with IN ketamine administration that has been mitigated with topical lidocaine (1). Eligible participants (defined in section 2.5 above) will be identified by the treating physician after viewing the radiographs and performing a clinical assessment. The physician will then inform a research assistant (RA) that the participant is eligible. The RA will then seek informed consent and explain the protocol to the family. Baseline demographic information will be obtained. Informed consent for PCS and a pre-anesthetic assessment will be performed by the treating physician in accordance with the usual standard of care. UMSS scores will be obtained by a trained RA at 5 minutes pre-intervention, intervention (0 minutes) and every 5 minutes thereafter for 60 minutes post-intervention or until the participant is ambulatory and drinking well, whichever is longer. Participants will receive standard monitoring of oxygen saturation, blood pressure, respiratory rate, apnea, heart rate, and rash by the attending nurse and physician every 5 minutes as per the usual standard of care. The usual standard of care also includes monitoring post-anesthetic for the presence of known idiosyncratic effects of ketamine that include vomiting, seizure, headache, emergence reaction, and hypersensitivity. The RA will obtain this information from the nursing record at discharge. Immediately prior to discharge, the RA will also record the duration of stay in the ED and parental satisfaction with PCS. 1. Chiaretti et al. 2011. Intranasal lidocaine and midazolam for procedural sedation in children. Arch Dis Child. 96;160-163
Open or close this module Conditions
Conditions: Bone Fractures
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 800 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Intranasal ketamine and saline
Intranasal ketamine (each single dose, 5 mg/kg prepared in 0.9% NS in 3 mL syringe and atomizer, to a maximum of 1.5 mL) PLUS IV 0.9% NS 5 mL
Drug: Ketamine and saline
Ketamine intravenous and intranasal
Other Names:
  • Ketamine hydrochloride
Active Comparator: Intravenous ketamine and saline
Intravenous ketamine (single dose, 1 mg/kg, to a maximum 100 mg) PLUS intranasal 0.9% NS 1.5 mL divided to both nares
Drug: Ketamine and saline
Ketamine intravenous and intranasal
Other Names:
  • Ketamine hydrochloride
Open or close this module Outcome Measures
Primary Outcome Measures:
1. University of Michigan Sedation Score
[ Time Frame: 20 minutes post intervention ]

The primary outcome is the median sedation score at 20 minutes post-intervention compared to 5 minutes pre-intervention (delta) using the University of Michigan Sedation Scale (UMSS)
Secondary Outcome Measures:
1. Time to recovery
[ Time Frame: 1 hour post sedation ]

Time to reach UMSS score of 0 in minutes
2. Duration of sedation
[ Time Frame: up to 5 min ]

Duration of sedation in minutes
3. Adverse events
[ Time Frame: 1 day ]

Frequency of adverse events
4. Length of stay
[ Time Frame: up to 5 min ]

ED length of stay in minutes
5. Parental satisfaction
[ Time Frame: 1 day ]

Parental satisfaction using a 5-item Likert scale
6. Adjunctive medication
[ Time Frame: 1 hour post intervention ]

Number of doses of adjunctive sedative medication required
7. Faces Pain Scale - revised
[ Time Frame: 1 day ]

Child's self reported pain score on wakening
Open or close this module Eligibility
Minimum Age: 5 Years
Maximum Age: 17 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Patients 5-17 years presenting to the paediatric ED who require a PCS for an acute simple orthopedic injuries who require a procedural conscious sedation (PCS). A "simple" injury is defined as a fracture or dislocation that: 1) requires no sustained traction (non-shortened) 2) is non-comminuted 3) is expected to be easily reduced within 20 minutes.

Exclusion Criteria:

  • 1) Previous hypersensitivity reaction to ketamine including rash, difficulty breathing, hypotension, apnea, or laryngospasm 2) Globe rupture 3) Traumatic brain injury with intracranial hemorrhage 4) Uncontrolled hypertension 5) Nasal bone deformity 6) Fracture reduction expected to require sustained traction, orthopedic consultation, or prolonged (> 20 minutes) procedural sedation 7) Poor English fluency 8) American Society of Anesthesiologists (ASA) class of 3 or greater
Open or close this module Contacts/Locations
Central Contact Person: Naveen P Poonai, MD
Telephone: 519 685 8500 Ext. 52011
Email: naveen.poonai@lhsc.on.ca
Central Contact Backup: Cindy Langford, RN
Telephone: 519 694 5309 Ext. 52011
Email: cindy.langford@lhsc.on.ca
Study Officials: Naveen Poonai, MD
Principal Investigator
Western University
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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