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Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises

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ClinicalTrials.gov Identifier: NCT02573714
Recruitment Status : Unknown
Verified March 2019 by Cameroon Baptist Convention Health.
Recruitment status was:  Recruiting
First Posted : October 12, 2015
Last Update Posted : March 14, 2019
Sponsor:
Collaborators:
Carolinas Medical Center
Muhimbili National Hospital
Information provided by (Responsible Party):
Cameroon Baptist Convention Health

Tracking Information
First Submitted Date  ICMJE October 8, 2015
First Posted Date  ICMJE October 12, 2015
Last Update Posted Date March 14, 2019
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2015)		 Change from Baseline (time zero) in FPS-R scores between treatment groups [ Time Frame: Baseline (time zero, indicated by injection of intranasal medication), 30 minutes, 60 minutes, and 120 minutes ]
Measure of differences of change of FPS-R scores from baseline to 30 minutes, 60 minutes, and 120 minutes compared between treatment arms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2015)
  • Hospital length of stay [ Time Frame: through study completion, an average of 3 days ]
    Hospital length of stay recorded from time zero to time of discharge documented by the study clinician will be a secondary outcome measure.
  • Quality of life assessment (PedsQL-SCD Module scores) [ Time Frame: Time of first intranasal administration to 3 weeks post intranasal intervention. ]
    PedsQL-SCD Module scores obtained by study clinicians using over-the-phone interviews between two-three weeks post intervention will be a secondary outcome measure.
  • Analgesia use - paracetamol [ Time Frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration ]
    Individual evaluation of total paracetamol use per kilogram body weight
  • Analgesia use - ibuprofen [ Time Frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration ]
    Individual evaluation of total ibuprofen use per kilogram body weight
  • Analgesia use - opioids [ Time Frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration ]
    Individual evaluation of total opioid use expressed as morphine equivalents per body weight.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 9, 2015)
  • Adverse Events [ Time Frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration ]
    Adverse events include: bad taste is mouth, drowsiness, dizziness, itchy nose, nausea, dysphoria, and other novel subjective negative experiences
  • Serious Adverse Events [ Time Frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration ]
    Serious adverse events include: apnea, assisted ventilation, bradypnea, cyanosis, dissociation, emergence reaction, hypotension, laryngospasm, myoclonus, seizure, and vomiting
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises
Official Title  ICMJE Comparison of Sub-dissociative Intranasal Ketamine Plus Standard Pain Therapy Versus Standard Pain Therapy in the Treatment of Pediatric Sickle Cell Disease Vasoocclusive Crises in Resource-limited Settings: a Multi-centered, Randomized, Controlled Trial
Brief Summary The purpose of this study is to determine if the use of ketamine, sniffed in the nose, is a safe and effective way to help reduce pain in pediatric sickle cell patients with pain crises in resource-limited settings.
Detailed Description This is a randomized, placebo-controlled, drug trial using sub-dissociative intranasal ketamine as an adjunct to standard pharmacotherapy for the management of pediatric sickle cell disease vasoocclusive pain crises in resource-poor settings. Pediatric patients will be enrolled at a teaching and referral hospital in West Africa. Patients will be randomly assigned to the treatment arm - standard therapy plus sub-dissociative intranasal ketamine (1 mg/kg) given at time zero) or the control arm - standard therapy plus intranasal normal saline (volume-matched to treatment arm), and patients will evaluated at standard intervals to assess for pain scores and vital signs (0 minutes, 30 minutes, 60 minutes, and 120 minutes). Pain will be assessed using the Faces Pain Scale - Revised (FPS-R). Patients will also be observed for any potential side effects or adverse events. All patients will be contacted 2-3 weeks post intranasal medication administration for over-the-phone follow-up using a portion of the PedsQL-SCD questionnaire, to assess for basic quality of life related to pain management and treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE
  • Drug: Ketamine
    Intranasal ketamine (concentration: 50 mg/ml, dose: 1 mg/kg) will be given at time zero. Intranasal administration will be performed by placing the needleless syringe gently into the nares with the patient sitting upright. Volumes of ≤ 0.75ml will be nasally inhaled in a single nare, while volumes > 0.75ml will be divided between both nares. Patients who are unable to inhale the medication nasally will receive drip administration of the same volume while recumbent on the bed.
  • Drug: Normal Saline
    Intranasal normal saline (placebo: volume-matched with intranasal ketamine) will be given at time zero. Intranasal administration will be performed by placing the needleless syringe gently into the nares with the patient sitting upright. Volumes of ≤ 0.75ml will be nasally inhaled in a single nare, while volumes > 0.75ml will be divided between both nares. Patients who are unable to inhale the medication nasally will receive drip administration of the same volume while recumbent on the bed.
    Other Name: NaCl 0.9%
  • Other: Standard Pain Therapy
    Typical management strategy for pediatric sickle cell disease vasoocclusive crises including acetaminophen/paracetamol, ibuprofen, oral opioids, and injectable opioids depending on pain severity.
  • Other: Pediatric Quality of Life - Sickle Cell Disease Module
    Standardized quality of life assessment performed 2-3 weeks post intranasal medication administration to evaluate pain management and severity of symptoms after discharge from the hospital.
    Other Name: PedsQL-SCD
  • Other: Faces Pain Scale - Revised
    All patients will answer the FPS-R at 0 minutes (immediately prior to receiving intranasal medication), 30 minutes, 60 minutes, and 120 minutes to assess current pain status.
    Other Name: FPS-R
Study Arms  ICMJE
  • Experimental: Intranasal Ketamine
    Patients allocated to receive intranasal ketamine (intervention) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.
    Interventions:
    • Drug: Ketamine
    • Other: Standard Pain Therapy
    • Other: Pediatric Quality of Life - Sickle Cell Disease Module
    • Other: Faces Pain Scale - Revised
  • Placebo Comparator: Normal Saline
    Patients allocated to receive intranasal normal saline (placebo) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.
    Interventions:
    • Drug: Normal Saline
    • Other: Standard Pain Therapy
    • Other: Pediatric Quality of Life - Sickle Cell Disease Module
    • Other: Faces Pain Scale - Revised
Publications *

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 9, 2015)		 160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sickle cell disease (SCD)
  • Vasoocclusive pain crisis
  • Requiring analgesia

Exclusion Criteria:

  • Anatomic variations of nose precluding intranasal medication administration
  • Ketamine allergy
  • Non-verbal
  • Obtunded
  • Pregnant

  • Other acute SCD complications:

    • Acute chest syndrome
    • Sepsis
    • Stroke
    • Splenic sequestration
    • Pulmonary embolism
    • Acute osteomyelitis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cameroon,   Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02573714
Other Study ID Numbers  ICMJE IRB2015-07
MNH/IRB/I/2015/14 ( Other Identifier: Muhimbili National Hospital IRB )
TFDA0015/CTR/0015/9 ( Other Identifier: Tanzania Food and Drugs Authority )
NIMR/HQ/R.8a/Vol. IX/2299 ( Other Identifier: Tanzania National Institute for Medical Research )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cameroon Baptist Convention Health
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cameroon Baptist Convention Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Carolinas Medical Center
  • Muhimbili National Hospital
Investigators  ICMJE
Study Director: Ernest Nshom, MD Cameroon Baptist Convention Health
Study Chair: Michael Runyon, MD Carolinas Medical Center
Principal Investigator: James R Young, MD Carolinas Medical Center
Study Director: Stacy Reynolds, MD Carolinas Medical Center
Study Director: Hendry R Sawe, MD Muhimbili University of Health and Allied Sciences
Study Director: Juma Mfinanga, MD Mihumbili National Hospital
PRS Account Cameroon Baptist Convention Health
Verification Date March 2019

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