Pediatric Ketamine Study for Pain Management

May 7, 2018 updated by: Antonios Likourezos

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ketamine
intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Drug: Ketamine
intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
ACTIVE_COMPARATOR: Fentanyl
intranasal fentanyl 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 Names:
  • Fetanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antonios Likourezos

Collaborators

Maimonides Medical Center

Investigators

  • Principal Investigator: Sabina Zavolkovskaya, MD, Maimonides Medical Center
  • Study Director: Sergey Motov, MD, Maimonides Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2015

Primary Completion (ACTUAL)

December 31, 2016

Study Completion (ACTUAL)

October 14, 2017

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

March 13, 2015

First Posted (ESTIMATE)

March 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-11-20-MMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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