Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intranasal Ketamine for Procedural Sedation (INK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02828566
Recruitment Status : Unknown
Verified March 2017 by Lawson Health Research Institute.
Recruitment status was:  Not yet recruiting
First Posted : July 11, 2016
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
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 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).

Condition or disease Intervention/treatment Phase
Bone Fractures Dislocations Drug: IN ketamine Drug: IV ketamine Drug: IN saline 0.9% Drug: IV saline 0.9% Phase 3

Detailed Description:
Randomization and concealment of allocation will be pharmacy-controlled using a computerized central randomization service. The treating physician, bedside nurse, 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 four or six to either (1) IN ketamine (each single dose, 10 mg/kg prepared in 0.9% NS in 3 mL syringe and atomizer, to a maximum of 8 mL) PLUS IV 0.9% NS 0.02 mL/kg or (2) IV ketamine (single dose, 1 mg/kg, to a maximum 80 mg) PLUS intranasal 0.9% NS 0.10 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. Adjunctive sedation will be given as needed in the form of IV ketamine, any dose, for participants who are adequately sedated 1 minute after IV administration at the discretion of the treating physician. Inadequate sedation in this context refers to one of the following: participant's vocalizations are consistent with pain OR participant withdraws or localizes due to pain. Eligible participants 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 PSA and a pre-anesthetic assessment will be performed by the treating physician in accordance with the usual standard of care. The RA will record a continuous video of the participant's entire body and monitor using an iPad starting immediately after the IV intervention until the participant is awake and able to tolerate oral fluids. DOCS scores will be obtained by two trained outcome assessors every 30 seconds for the entire duration of the video. The outcome assessors will also score the entire video for emergence delirium using the Paediatric Anesthesia Emergence Delirium (PAED) scale every 5 minutes beginning at the completion of fracture reduction until the participant is awake and drinking. 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 and based on consensus-based Canadian recommendations. Immediately prior to discharge, the RA will also record the duration of stay in the ED, parental, patient, and physician satisfaction with PSA using a 5-item Likert scale, and nasal irritation

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 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 Sedation in Children: a Multi-centre Randomized Controlled Non-inferiority Trial
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: IN ketamine and IV saline
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
Intranasal ketamine 100 mg/mL solution (10 mg/kg, maximum 800 mg)
Other Name: ketamine hydrochloride

Drug: IV saline 0.9%
Intravenous 0.9% normal saline

Active Comparator: IV ketamine and IN saline
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
Intravenous ketamine 50 mg/mL solution (1 to 1.5 mg/kg, maximum 120 mg)
Other Name: ketamine hydrochloride

Drug: IN saline 0.9%
Intranasal 0.9% normal saline




Primary Outcome Measures :
  1. Adequacy of sedation [ Time Frame: Duration of fracture reduction ]
    Proportion with DOCS score -2 to +2 for duration of fracture reduction


Secondary Outcome Measures :
  1. Depth of sedation [ Time Frame: Duration of fracture reduction ]
    Score using Pediatric Sedation State Scale

  2. Onset of adequate sedation [ Time Frame: Within 1 hour following intervention ]
    Time interval from first IN sprays to first DOCS score between -2 and +2 in minutes

  3. Duration of sedation [ Time Frame: Within 2 hours following intervention ]
    Duration of time between the first DOCS score -2 to +2 to last DOCS score between -2 and +2 post-fracture reduction

  4. Proportion of time participant adequately sedated during fracture reduction [ Time Frame: Within 2 hours following intervention ]
    Proportion of time DOCS score is -2 to +2 during fracture reduction.

  5. Adverse events [ Time Frame: Within 2 hours following intervention ]
    The proportion of participants with adverse effects between groups will be compared. The list of adverse effects was chosen based on known adverse effects associated with ketamine and consensus-based recommendations for reporting for procedural sedation and analgesia in children.

  6. Length of stay due to PSA [ Time Frame: Within 3 hours of intervention ]
    Time interval from the first pair of IN sprays to discharge

  7. Duration of procedure [ Time Frame: Within 3 hours of intervention ]
    Time of the first pair of IN sprays to the end of cast or splint application

  8. Caregiver satisfaction [ Time Frame: Within 2 hours of intervention ]
    Obtained when patient is awake and drinking using a Visual Analog Scale; Parents not wishing to remain in proximity of child for sedation may opt out

  9. Participant satisfaction [ Time Frame: Within 2 hours of intervention ]
    Obtained when patient is awake and drinking using a Visual Analog Scale; Satisfaction will only be assessed in children at least eight years of age as the VAS has not been validated in younger children.

  10. Physician satisfaction [ Time Frame: Within 2 hours of intervention ]
    Obtained immediately prior to discharge using a Visual Analog Scale

  11. Nurse satisfaction [ Time Frame: Within 2 hours of intervention ]
    Obtained immediately prior to discharge using a Visual Analog Scale

  12. Requirement for additional sedative medication [ Time Frame: Within 2 hours of intervention ]
    Number of doses and type of adjunctive sedative medication required; Deemed inadequate if additional sedative medication given (for IN ketamine group only)

  13. Analgesic medication [ Time Frame: Within 2 hours of intervention ]
    Number of doses and type of analgesic medication required

  14. Pain [ Time Frame: Within 2 hours of intervention ]
    Pain scores will be recorded using the FPS-R on arrival and when the child is awake and drinking

  15. Emergence delirium [ Time Frame: 20 to 80 minutes post-IV intervention ]
    The proportion of children experiencing emergence delirium will be compared using the Paediatric Anesthesia Emergence Delirium (PAED) scale scored from the video every 5 minutes by an outcome assessor starting when fracture reduction is complete to when awake and drinking

  16. Nasal irritation [ Time Frame: Within 2 hours following intervention ]
    Measured using the Faces Pain Scale - Revised when awake and drinking

  17. Successful sedation [ Time Frame: Within 2 hours following intervention ]

    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


  18. Adjunctive IV therapy [ Time Frame: Within 2 hours following intervention ]
    Other reasons for IV insertion (analgesia, anxiolysis, fluids, etc.)

  19. Number of IN sprays received / Intended number of sprays [ Time Frame: Within 2 hours following intervention ]
    Number of IN sprays received / Intended number of sprays

  20. Number of IV attempts [ Time Frame: Within 2 hours following intervention ]
    Number of IV attempts and time to IV insertion Number of IV attempts

  21. Time to IV insertion [ Time Frame: Within 2 hours following intervention ]
    Time from first breakage of skin to establishment of successful flow with a flush



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previous hypersensitivity reaction to ketamine
  2. Globe rupture
  3. Traumatic brain injury with intracranial hemorrhage
  4. History of uncontrolled hypertension
  5. Nasal bone deformity
  6. Duration of reduction expected to be greater than 20 minutes
  7. Poor English or French fluency in the absence of a native language interpreter
  8. American Society of Anesthesiologists (ASA) class of 3 or greater
  9. Previous sedation with ketamine within 24 hours
  10. Previous diagnosis of schizophrenia or psychosis based on DSM-V criteria
  11. Pregnancy
  12. Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction
  13. Multi-limb trauma
  14. Hemodynamic compromise
  15. Glasgow coma score < 15
  16. Fracture is comminuted
  17. Fracture is associated with a dislocation
  18. Hematoma block at index visit
  19. Unilateral or bilateral nasal obstruction (due to infectious or allergic rhinitis, nasal polyps, septal hematoma, or septal deviation)

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): NCT02828566


Contacts
Layout table for location contacts
Contact: Naveen Poonai, MD 5196858500 ext 52011 naveen.poonai@lhsc.on.ca
Contact: Cindy Langford, RN 5196858500 ext 52011 cindy.langford@lhsc.on.ca

Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Naveen Poonai, MD Western University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02828566    
Other Study ID Numbers: 106550
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Wounds and Injuries
Ketamine
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