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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

Tracking Information
First Submitted Date  ICMJE March 25, 2015
First Posted Date  ICMJE March 30, 2015
Last Update Posted Date August 14, 2018
Study Start Date  ICMJE January 2016
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2016)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
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)
Change History Complete list of historical versions of study NCT02402868 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
  • 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
  • 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
  • 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
  • Length of stay [ Time Frame: Within 3 hours of intervention ]
    Time from arrival in ED bed to discharge in minutes
  • Length of stay due to sedation [ Time Frame: Within 3 hours of intervention ]
    Time from first IN spray to discharge in minutes
  • Duration of procedure [ Time Frame: Within 3 hours of intervention ]
    Time from first IN spray to end of cast application
  • 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
  • Child satisfaction [ Time Frame: Within 2 hours of sedation ]
    Obtained immediately prior to discharge using a 5-item Likert scale
  • Sedating physician satisfaction [ Time Frame: Duration of ED visit ]
    Obtained immediately prior to discharge using a 5-item Likert scale
  • Adjunctive sedative medication [ Time Frame: Duration of ED visit ]
    Number of doses and type of adjunctive sedative medication required
  • Analgesic medication [ Time Frame: Duration of ED visit ]
    Number of doses and type of analgesic medication required
  • Pain [ Time Frame: 15 minutes prior to and 2 hours post intervention ]
    Child's self reported pain score using the Faces Pain Scale - Revised
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
  • Time to recovery [ Time Frame: 1 hour post sedation ]
    Time to reach UMSS score of 0 in minutes
  • Duration of sedation [ Time Frame: up to 5 min ]
    Duration of sedation in minutes
  • Adverse events [ Time Frame: 1 day ]
    Frequency of adverse events
  • Length of stay [ Time Frame: up to 5 min ]
    ED length of stay in minutes
  • Parental satisfaction [ Time Frame: 1 day ]
    Parental satisfaction using a 5-item Likert scale
  • Adjunctive medication [ Time Frame: 1 hour post intervention ]
    Number of doses of adjunctive sedative medication required
  • Faces Pain Scale - revised [ Time Frame: 1 day ]
    Child's self reported pain score on wakening
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children
Official Title  ICMJE Intranasal Ketamine Versus Intravenous Ketamine for Procedural Conscious Sedation in Children: a Multi-centre Randomized Controlled Non-inferiority Trial
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, 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bone Fractures
Intervention  ICMJE Drug: Ketamine and saline
Ketamine intravenous and intranasal
Other Name: Ketamine hydrochloride
Study Arms  ICMJE
  • 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
    Intervention: Drug: Ketamine and saline
  • 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
    Intervention: Drug: Ketamine and saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2018)
17
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2015)
800
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02402868
Other Study ID Numbers  ICMJE 106549
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Naveen Poonai, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Naveen Poonai, MD Western University
PRS Account Lawson Health Research Institute
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP