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NMDA Receptor Antagonist

Nebulized Ketamine for Pediatric Acute Pain

Phase 4

Recruiting

Research Sponsored by Antonios Likourezos

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Vaso-occlusive painful crisis of sickle cell disease, and lacerations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 minutes

Awards & highlights

Study Summary

This trial found that nebulized fentanyl was safe and effective in treating pediatric patients with acute pain from musculo-skeletal injuries in the emergency department, and that it was comparable to intravenous fentanyl and intravenous morphine.

Who is the study for?

This trial is for kids aged 7-17 who come to the ED with acute pain, scoring at least a 5 on a pain scale. It includes various pains like abdominal and musculoskeletal. Kids must have taken acetaminophen or ibuprofen before getting SDK. Those with seizures, mental disorders, no parent present, pregnancy, airway issues, altered consciousness, allergy to ketamine, weight over 100 kg or high heart rate can't join.Check my eligibility

What is being tested?

The study tests nebulized ketamine for emergency pain relief in kids when IVs aren't an option. Three doses (0.75 mg/kg, 1 mg/kg and 1.5 mg/kg) are compared to find the best one without needing needles.See study design

What are the potential side effects?

Ketamine may cause side effects such as dizziness, nausea, mood changes or hallucinations; however specific side effects of nebulized form in this dosage range will be closely monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 7 and 17 years old and my pain score is 5 or more.

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I have had painful episodes due to sickle cell disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain Score reduction from baseline

Trial Design

3Treatment groups

Active Control

Group I: 0.75 mg/kgActive Control1 Intervention

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.

Group II: SDK: 1 mg/kgActive Control1 Intervention

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.

Group III: SDK: 1.5 mg/kg.Active Control1 Intervention

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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Antonios LikourezosLead Sponsor

38 Previous Clinical Trials

8,458 Total Patients Enrolled

17 Trials studying Pain

1,305 Patients Enrolled for Pain

John Marshall, MDStudy ChairMaimonides Medical Center

8 Previous Clinical Trials

333 Total Patients Enrolled

3 Trials studying Pain

180 Patients Enrolled for Pain

Media Library

Nebulized Sub-dissociative Dose Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03950817 — Phase 4

Pain Research Study Groups: 0.75 mg/kg, SDK: 1 mg/kg, SDK: 1.5 mg/kg.

Pain Clinical Trial 2023: Nebulized Sub-dissociative Dose Ketamine Highlights & Side Effects. Trial Name: NCT03950817 — Phase 4

Nebulized Sub-dissociative Dose Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03950817 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study accept elderly participants?

"The target population for this trial consists of individuals aged 7 to 17 years."

Answered by AI

Who has the opportunity to participate in this medical experiment?

"This clinical trial is accepting roughly 120 minors between the ages of 7 and 17 who are suffering from pain."

Answered by AI

Are any openings currently available in this research project?

"Affirmative. Clinicaltrials.gov data confirms that this experiment, which was originally posted on May 13th 2019, is presently seeking to recruit 120 volunteers from a singular medical institution."

Answered by AI

How many individuals can feasibly participate in this medical experiment?

"Affirmative. Clinicaltrials.gov houses data indicating that the trial, which was first made available on May 13th 2019 is presently recruiting participants. The clinical study requires 120 individuals to be sourced from 1 medical centre."

Answered by AI