NCT04330183: LDK-SCD

Low Dose Ketamine and Acute Pain Crisis

Completed Phase 4 Last updated 23 December 2021

What this trial tests

Phase 4 trial testing Ketamine in Sickle Cell Crisis in 20 participants. Completed in 1 October 2021.

Timeline

1 July 2020

Primary endpoint
1 October 2021

1 October 2021

Quick facts

Lead sponsor	Rhode Island Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	20
Start date	1 July 2020
Primary completion	1 October 2021
Estimated completion	1 October 2021
Sites	2 locations across United States

Drugs / interventions tested

• Ketamine (ketamine) — full drug profile →
• Normal Saline

Conditions studied

• Sickle Cell Crisis — all drugs for Sickle Cell Crisis →

Sponsor

Rhode Island Hospital

Who can join

18 and older, any sex, with Sickle Cell Crisis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations.
   Vekhova KA, Namiot ED, Jonsson J, Schiöth HB. · · 2025 · cited 17× · PMID 39428602 · DOI 10.1002/cpt.3478
2. Letter to the Editor: Role of Ketamine in Vaso-Occlusive Crisis of Sickle Cell Disease.
   Raghuraman MS. · · 2022 · PMID 35283701 · DOI 10.4103/sjmms.sjmms_234_21