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Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children

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ClinicalTrials.gov Identifier: NCT02402868
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Naveen Poonai, Lawson Health Research Institute

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).

Condition or disease Intervention/treatment Phase
Bone Fractures Drug: Ketamine and saline Phase 3

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, 8 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 0.02 mL/kg or (2) IV ketamine (single dose, 1 mg/kg, to a maximum 100 mg) PLUS intranasal 0.9% NS 0.08 mL/kg 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 4). A figure of the atomizer device used to deliver the IN agent has been uploaded. 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Ketamine Versus Intravenous Ketamine for Procedural Conscious Sedation in Children: a Multi-centre Randomized Controlled Non-inferiority Trial
Study Start Date : January 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Intranasal ketamine and saline
Intranasal ketamine (each single dose, 8 mg/kg prepared in 0.9% NS in 3 mL syringe and atomizer, to a maximum of 6.4 mL) PLUS IV 0.9% NS 0.02 mL/kg
Drug: Ketamine and saline
Ketamine intravenous and intranasal
Other Name: 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 0.08 mL/kg divided to both nares
Drug: Ketamine and saline
Ketamine intravenous and intranasal
Other Name: Ketamine hydrochloride




Primary Outcome Measures :
  1. University of Michigan Sedation Score [ Time Frame: From the time the IV intervention is given to 60 minutes post intervention or when drinking, whichever is longer ]
    The primary outcome is the UMSS score at 10 minutes post administration of the IV intervention compared to UMSS score immediately prior to the first IN intervention (delta) using the University of Michigan Sedation Scale (UMSS)


Secondary Outcome Measures :
  1. Onset of sedation [ Time Frame: Within 1 hour following intervention ]
    Time interval from first IN spray to UMSS score of greater than 3 in minutes

  2. Duration of sedation [ Time Frame: Within 2 hours following sedation ]
    Time interval from UMSS score greater than 3 to a UMSS score of 0 in minutes

  3. Adverse events [ Time Frame: Within 2 hours following sedation ]
    Obtained when patient fully awake and prior to discharge from the participant, physician report and corroborated with nursing sedation record

  4. Length of stay [ Time Frame: Within 3 hours of intervention ]
    Time from arrival in ED bed to discharge in minutes

  5. Length of stay due to sedation [ Time Frame: Within 3 hours of intervention ]
    Time from first IN spray to discharge in minutes

  6. Duration of procedure [ Time Frame: Within 3 hours of intervention ]
    Time from first IN spray to end of cast application

  7. Parental satisfaction [ Time Frame: Within 2 hours of sedation ]
    Obtained immediately prior to discharge using a 5-item Likert scale; Parents not wishing to remain in proximity of child for sedation may opt out

  8. Child satisfaction [ Time Frame: Within 2 hours of sedation ]
    Obtained immediately prior to discharge using a 5-item Likert scale

  9. Sedating physician satisfaction [ Time Frame: Duration of ED visit ]
    Obtained immediately prior to discharge using a 5-item Likert scale

  10. Adjunctive sedative medication [ Time Frame: Duration of ED visit ]
    Number of doses and type of adjunctive sedative medication required

  11. Analgesic medication [ Time Frame: Duration of ED visit ]
    Number of doses and type of analgesic medication required

  12. Pain [ Time Frame: 15 minutes prior to and 2 hours post intervention ]
    Child's self reported pain score using the Faces Pain Scale - Revised

  13. Emergence Agitation [ Time Frame: Every 5 minutes for 60 minutes starting 20 minutes post IV intervention ]
    Degree of emergency agitation and delirium as recorded by observer using the Paediatric Anesthesia Emergency Delirium (PAED) scale

  14. Nasal Irritation [ Time Frame: Within 1 hour of intervention ]
    Recorded using a 5-item Likert scale anchored from 1=none to 5=very severe when child has a UMSS score of 0 and is awake and drinking

  15. Successful sedation [ Time Frame: From time of first IN spray to when participant is fully awake (UMSS score of 0 for 15 minutes) ]

    Successful sedation - Based on the definition of Bhatt et al., this will be defined as no unpleasant patient recall of the procedure, no resistance or restraint required during the procedure, no permanent sedation-related complication or no sedation-related event requiring abandonment of the procedure.

    Defined as: no unpleasant patient recall of the procedure, no resistance or restraint required during the procedure, no permanent sedation-related complication or no sedation-related event requiring abandonment of the procedure.

    Defined as no unpleasant recall of procedure, no resistance or restraint, no permanent sedation related complication, no sedation-related event requiring abandonment of procedure




Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 5-17 years (up to 80 kg) presenting to the paediatric ED who require a PCS for an acute simple orthopedic injuries who require a procedural sedation and analgesia (PSA). A "simple" injury is defined as a fracture or dislocation that: 1) Angulated with or without displacement but is not shortened) 2) Non-comminuted

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) History of uncontrolled hypertension 5) Nasal bone deformity 6) Fracture reduction expected to require > 20 minutes 7) Poor English fluency 8) American Society of Anesthesiologists (ASA) class of 3 or greater 9) Previous sedation with ketamine within 24 hours of index visit 10) Known diagnosis of schizophrenia or active psychosis 11) Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402868


Locations
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Canada, Ontario
Children's Hospital, London Health Sciences Centre
London, Ontario, Canada, N6A5W9
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Naveen Poonai, MD Western University

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Responsible Party: Naveen Poonai, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02402868     History of Changes
Other Study ID Numbers: 106549
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ketamine
Fractures, Bone
Wounds and Injuries
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action