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

NCT03950817 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2019-01-05
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain Score Reduction From Baseline

  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. (Pain score at Baseline - Pain Score at 15 minutes)

  15 minutes

Study Arms (3)

0.75 mg/kg

ACTIVE COMPARATOR

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

SDK: 1 mg/kg

ACTIVE COMPARATOR

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

SDK: 1.5 mg/kg.

ACTIVE COMPARATOR

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.

Interventions

Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg DRUG

Nebulized Sub-dissociative Dose Ketamine at 0.75 mg/kg

0.75 mg/kg

Nebulized Sub-dissociative Dose Ketamine at 1 mg/kg DRUG

Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg.

SDK: 1 mg/kg

Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg. DRUG

Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg.

SDK: 1.5 mg/kg.

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Sergey Motov (Director of Emergency Medicine Research)
• Organization: Maimonides Medical Center

smotov@maimo.org

718-283-8693

Study Officials

• John Marshall, MD

  Maimonides Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 15, 2019
• Study Start: May 13, 2019
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)