Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04330183 · ClinicalTrials.gov registry record · Phase 4
Low Dose Ketamine and Acute Pain Crisis
A Phase 4 study, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT04330183 is a Phase 4 study that has completed, run by Rhode Island Hospital. The registered enrollment target is 20 participants.
The verdict
NCT04330183, a Phase 4 study, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
BACKGROUND: Current treatment standard for acute pain crisis in sickle cell disease (SCD) is largely supportive care: opioid analgesics, hydration, oxygen, and blood transfusion. Sickle cell disease (SCD) is a chronic condition associated with serious and disabling acute consequences such as a vaso-occlusive (VOC) or pain crisis. Uncontrolled pain is the hallmark of a VOC, and often results in acute unscheduled care in the patient's clinic or hospital emergency department (ED). During these pain crises, patients sometimes require high doses of opioids for analgesia. Opioid analgesics are fraught with challenges including the development of tolerance, dependence, and opioid-induced hyperalgesia (whereby the use of opioids actually makes patients more sensitive to pain). Finding non-opioid alternatives for intravenous analgesia is problematic based on the limited availability this class of drugs. Ketamine is a potent N-methyl-D-aspartate (NMDA) receptor antagonist that even at low doses has demonstrated efficacy as an adjunct to opioids for acute pain control. OBJECTIVE: The investigators will determine the comparative efficacy of low doses of ketamine as an adjunct to opioids versus standard care (opioids alone) for the treatment of acute severe pain in patients with sickle cell related pain crisis. METHODS: The investigators propose a double-blinded, randomized, placebo-controlled pilot study to determine the efficacy of ketamine 0.3mg/kg vs. placebo for the treatment of acute pain crisis. The investigators will include all eligible emergency department ≥18 years. The investigators will stratify 42 patients by location, 21 patients per site. Numeric Rating Scale (NRS) will be recorded as a part of the study log at 0, 1, 2 and 3hrs after the study drug administration. HYPOTHESIS: The investigators hypothesize that the ketamine will decrease overall pain intensity, visit length of stay, and hospitalizations.
Interventions
- DRUG Ketamine
- DRUG Normal Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2021-10-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04330183
The ClinicalTrials.gov registry entry for NCT04330183 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhode Island Hospital, which has 130 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ketamine is the first listed.
NCT04330183 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04330183 about?
NCT04330183 is a clinical study titled "Low Dose Ketamine and Acute Pain Crisis". BACKGROUND: Current treatment standard for acute pain crisis in sickle cell disease (SCD) is largely supportive care: opioid analgesics, hydration, oxygen, and blood transfusion. Sickle cell disease (SCD) is a chronic condition associated with serious and disabling acute consequences such as a vaso...
What is the current status of trial NCT04330183?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2020-07-01. Estimated completion is 2021-10-01.
What interventions are being tested in trial NCT04330183?
The interventions under investigation include: Ketamine (DRUG), Normal Saline (DRUG).
Who is sponsoring clinical trial NCT04330183?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.