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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: Completed Phase 4 study, sponsored by Rhode Island Hospital.
NCT04330183 is a Phase 4 study that has completed, run by Rhode Island Hospital. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
We anticipate a decrease in numeric pain score after ketamine administration
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 |
What the finished NCT04330183 record still lists
NCT04330183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Ketamine is the first listed.
NCT04330183 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04330183's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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