Adults 18 to 120, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Pain Scores From Baseline to 30 MinutesPrimary· 30 minutes
Patients will be assessed via an 11 point Likert numeric rating scale at time medication is given (baseline) and 30 minutes later. The difference in pain scores will be assessed between the 3 groups. The numeric rating scale range is from 0 to 10 with 0 being no pain and 10 being very severe pain.
Group
Value
95% CI
SDK 0.75 mg/kg
4.0
± 1.9
SDK 1.0 mg/kg
4.2
± 2.1
SDK 1.5 mg/kg
4.1
± 1.9
Adverse events — posted to ClinicalTrials.gov
Time frame: 120 minutes.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The investigators previous research study comparing the efficacy of intravenous ketamine to morphine showed ketamine to provide equivalent relief of moderate to severe acute pain in emergency department patients. A second study by the investigators showed that increasing the time of administration of the ketamine, from a push injection to a drip infusion, will minimize the adverse effects experienced by recipients of ketamine.
The investigators now aim to see if nebulized subdissociative-dose ketamine administered as a single agent in a dose of 1.5 mg/kg via Breath-Actuated Nebulizers (BAN) over 5-15 minutes will provide a better pain relief in comparison to 1 mg/kg and 0.75 mg/kg doses or if the lower doses are equally as effective.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Antonios Likourezos
Last refreshed: 15 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03909607.