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Nebulized Sub-dissociative Dose Ketamine at Three Different Dosing Regimens for Treating Acute Pain in the Pediatric ED

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ClinicalTrials.gov Identifier: NCT03950817
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Brief Summary:
In the situation when intravenous access is not readily available or unobtainable, sub-dissociative dose ketamine can be administered via intranasal route (IN). The data supporting intranasal route in pediatric patients is somewhat conflicting with regards to the optimum intranasal dose (range 0.75-1 mg/kg) and frequencies of administration. Hence, another non-invasive route such as nebulization via Breath-Actuated Nebulizer which allows a controlled patient-initiated delivery of analgesics in titratable fashion might be considered in the ED. Administration of fentanyl via BAN for pediatric patients presenting to the ED with acute traumatic musculo-skeletal injuries was found to be safe and effective and comparable to intravenous fentanyl and intravenous morphine. Nebulized administration of ketamine however, has only been studied in the areas of acute postoperative pain management, cancer palliation, and status asthmaticus therapy (ref). To our knowledge, there are no prospective randomized trials that evaluated a role of nebulized SDK role in managing a variety of acute and chronic painful conditions in the ED.

Condition or disease Intervention/treatment Phase
Pain Drug: Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg Drug: Nebulized Sub-dissociative Dose Ketamine at 1 mg/kg Drug: Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg. Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Nebulized Sub-dissociative Dose Ketamine at Three Different Dosing Regimens for Treating Acute Pain in the Pediatric ED: A Prospective, Randomized Double-Blind Trial
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: 0.75 mg/kg
The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses of 0.75 mg/kg sub-dissociative dose ketamine (SDK) to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.
Drug: Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg
Nebulized Sub-dissociative Dose Ketamine at 0.75 mg/kg

Active Comparator: SDK: 1 mg/kg
The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses 1 mg/kg sub-dissociative dose ketamine (SDK), to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.
Drug: Nebulized Sub-dissociative Dose Ketamine at 1 mg/kg
Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg.

Active Comparator: SDK: 1.5 mg/kg.
The on-duty ED pharmacist will prepare a breath-actuated nebulizer with doses of 1.5 mg/kg sub-dissociative dose ketamine (SDK), to give to ED pediatric patients with moderate to severe pain based on a score of 0 to 10 on a Visual Analog scale where 0 is no pain, 5 is moderate pain and 10 is very severe pain.
Drug: Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg.
Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg.




Primary Outcome Measures :
  1. Pain Score reduction from baseline [ Time Frame: 15 minutes ]
    The primary outcome will include a comparative reduction in pain scores on numeric rating pain scale (NRS) between recipients of nebulized SDK given at three different doses at 15 minutes after analgesic administration. The Visual Analog Scale Ranges from 0 (no pain) to 10 (bery severe pain) with 5 being moderate pain



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ages between 7 and 17 presenting to the ED
  • with acute painful conditions; score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.
  • traumatic and non-traumatic abdominal pain
  • flank pain
  • back ,pain
  • musculoskeletal pain,
  • vaso-occlusive painful crisis of sickle cell disease, and lacerations with a
  • Patients receiving oral acetaminophen and/or ibuprofen at triage prior to SDK administration

Exclusion Criteria:

  • altered mental status,
  • GCS<15,
  • allergy to ketamine,
  • pregnant patients,
  • weight greater than 100 kg,
  • heart rate >180,
  • airway abnormalities ( congenital or acquired), absence of parent(s) at the time of consent,
  • closed head injury,
  • seizure disorder,
  • use of opioid analgesics,
  • schizophrenia or bipolar disorder

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): NCT03950817


Contacts
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Contact: Antonios Likourezps, MPH 7182836896 alikourezos@maimonidesmed.org
Contact: Sergey Motov, MD 7182838693 smotov@maimonidesmed.org

Locations
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United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Antonios Likourezos, MPH       alikourezos@maimonidesmed.org   
Contact: Sergey Motov, MD       smotov@maimonidesmed.org   
Sponsors and Collaborators
Antonios Likourezos
Investigators
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Study Chair: John Marshall, MD Maimonides Medical Center
  Study Documents (Full-Text)

Documents provided by Antonios Likourezos, Maimonides Medical Center:

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Responsible Party: Antonios Likourezos, Research Manager, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT03950817     History of Changes
Other Study ID Numbers: 2019-01-05
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
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