Phase 4
Completed N=120
Nebulized Sub-dissociative Dose Ketamine for Treating Pain
Source: ClinicalTrials.gov NCT03909607 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Change in Pain Scores From Baseline to 30 Minutes — 4.0; 4.2; 4.1 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Scores From Baseline to 30 Minutes |
4.0; 4.2; 4.1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients age 18 and older
- acute and chronic abdominal, flank, back, musculoskeletal pain, and traumatic pain as well as cancer pain
- initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.
Exclusion Criteria
- altered mental status,
- allergy to ketamine,
- weight greater than 150 kg,
- unstable vital signs (systolic blood pressure 180 mm Hg,
- pulse rate 150 beats/min,
- respiration rate 30 breaths/min)
- alcohol or drug abuse
- inability to provide consent
- psychiatric illness (schizophrenia),
- recent (4 hours before) opioid use.
Data sourced from ClinicalTrials.gov (NCT03909607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.