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Pediatric Ketamine Study for Pain Management

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ClinicalTrials.gov Identifier: NCT02388321
Recruitment Status : Terminated (Patients meeting inclusion criteria was low, and PI went to another institution.)
First Posted : March 17, 2015
Results First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Maimonides Medical Center
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Tracking Information
First Submitted Date  ICMJE February 9, 2015
First Posted Date  ICMJE March 17, 2015
Results First Submitted Date  ICMJE March 26, 2018
Results First Posted Date  ICMJE May 8, 2018
Last Update Posted Date May 8, 2018
Actual Study Start Date  ICMJE May 1, 2015
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
Pain Score at 30 Minutes [ Time Frame: 30 minutes ]
An 11 point Likert Visual Analog Scale with 0 being no pain, 5 being moderate pain and 10 being very severe pain was verbally administered to the patient at 30 minutes post administration of analgesia.
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2015)
  • Pain score at 10 minutes [ Time Frame: 10 minutes ]
    Pain score at 10 minutes
  • Pain score at 20 minutes [ Time Frame: 15 minutes ]
    Pain score at 20 minutes
  • Pain score at 30 minutes [ Time Frame: 30 minutes ]
    Pain score at 30 minutes
  • Pain score at 60 minutes [ Time Frame: 60 minutes ]
    Pain score at 60 minutes
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
Adverse Events at 30 Minutes [ Time Frame: 30 minutes ]
The patient were asked at 30 minutes post administration of analgesia if they experienced any side effects like nausea, vomiting, headache etc.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2015)
  • Adverse Events at 10 minutes [ Time Frame: 10 minutes ]
    Adverse Events at 10 minutes
  • Adverse Events at 20 minutes [ Time Frame: 15 minutes ]
    Adverse Events at 20 minutes
  • Adverse Events at 30 minutes [ Time Frame: 30 minutes ]
    Adverse Events at 30 minutes
  • Adverse Events at 60 minutes [ Time Frame: 60 minutes ]
    Adverse Events at 60 minutes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pediatric Ketamine Study for Pain Management
Official Title  ICMJE Comparison of Sub-dissociative Dose Intranasal Ketamine to Intranasal Fentanyl for Treatment of Moderate to Severe Pain in Pediatric Patients Presenting to the Emergency Department: a Prospective, Randomized, Double-blind Study
Brief Summary Direct comparison of intranasal sub-dissociative dose ketamine with intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Detailed Description

Intranasal (IN) delivery of analgesic agents provides rapid and convenient drug administration without the need for needles. In children, the placement of an intravenous line often increases anxiety and pain, requires nursing time, and can be very difficult to achieve, so the IN route is particularly advantageous. IN delivery of fentanyl has become increasingly more common in pain management for children in many settings, including pre-hospital and emergency department (ED) settings. Over the past decade, many studies have demonstrated that intranasal fentanyl is as effective as intravenous morphine to treat acute moderate to severe pain. Intranasal fentanyl has become standard of care in some pediatric EDs with the advantage of avoiding intravenous line placement. However, adverse effects attributed to IN fentanyl are similar to those of other opioid analgesics: hypotension, sedation, and occasionally respiratory depression. Ketamine is a noncompetitive N-methyl D-aspartate (NMDA) receptor antagonist that blocks the release of the excitatory neurotransmitter glutamate and provides anesthesia, amnesia, and analgesia by decreasing central sensitization and "wind-up" phenomenon. Due to its high lipid solubility, ketamine rapidly crosses the blood-brain barrier, provides rapid onset of action (peak concentration at 1 minute after intravenous push) and rapid recovery to baseline (duration of action 5-15 minutes after intravenous push). At sub-dissociative doses, either used as an adjunct to opioid analgesics or as a solo agent, ketamine provides effective analgesia while preserving airway patency, ventilation, and cardiovascular stability.

Ketamine has been less studied for pain management, however it has been safely used via different routes of administration in children. Studies dating back to 1990's use ketamine at doses as high as 6 mg/kg intranasally in children for pre-medication prior to surgery or for sedation with little or no reported adverse effects. A hospital in Australia is currently conducting a clinical trial comparing IN fentanyl 1.5 ug/kg to IN ketamine 1mg/kg for the treatment of pain caused by isolated musculoskeletal injury. The intention of our study is similar to this, however the investigators will not limit the patients to those with only musculoskeletal pain and a more simplified pain scale will be used.

To assess pain, the investigators will use the standard pain scale that is currently used in our Pediatric ED in order to minimize the need to re-train any of our staff with a different pain scale. The scale incorporates the Numerical rating scale (0-10 scale; NRS) and the Wong-Baker faces pain scale (6 faces corresponding to 0,2,4,6,8,10; WBS). While prior studies have used different pain scales, primarily the visual analog scale (VAS), the scales that the investigator currently use have been validated in children in 2009.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Ketamine
    intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
  • Drug: Fentanyl
    intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
    Other Name: Fetanyl
Study Arms  ICMJE
  • Experimental: Ketamine
    intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
    Intervention: Drug: Ketamine
  • Active Comparator: Fentanyl
    intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
    Intervention: Drug: Fentanyl
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 Terminated
Actual Enrollment  ICMJE
 (submitted: September 2, 2017)
22
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2015)
80
Actual Study Completion Date  ICMJE October 14, 2017
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children aged 3-17,
  • weighing less than 50kg
  • present to the pediatric ED with moderate-severe acute pain (defined as pain greater than or equal to 6/10).
  • Treating physician determines the patient to require opioid analgesia.

Exclusion Criteria:

  • Children with facial trauma or any abnormal nasal anatomy;
  • developmentally delayed children;
  • children with head trauma/increased intracranial pressure (ICP);
  • children with known allergy to fentanyl or ketamine;
  • children who are unable to provide pain scale assessment;
  • children with chronic pain of greater than 4 weeks;
  • Pregnant females;
  • and children with a Glasgow Coma Scale (GCS)<15.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02388321
Other Study ID Numbers  ICMJE 2014-11-20-MMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antonios Likourezos, Maimonides Medical Center
Study Sponsor  ICMJE Antonios Likourezos
Collaborators  ICMJE Maimonides Medical Center
Investigators  ICMJE
Principal Investigator: Sabina Zavolkovskaya, MD Maimonides Medical Center
Study Director: Sergey Motov, MD Maimonides Medical Center
Study Chair: John Marshall, MD Maimonides Medical Center
PRS Account Maimonides Medical Center
Verification Date October 2017

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