NCT00595530

Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain

Terminated Phase 2 Results posted Last updated 21 August 2019

What this trial tests

Phase 2 trial testing ketamine in Sickle Cell Disease in 3 participants. Terminated before completion.

Timeline

4 March 2008

Primary endpoint
12 February 2010

12 February 2010

Quick facts

Lead sponsor	Connecticut Children's Medical Center
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	4 March 2008
Primary completion	12 February 2010
Estimated completion	12 February 2010
Sites	2 locations across United States

Drugs / interventions tested

• ketamine (ketamine) — full drug profile →

Conditions studied

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

Sponsor

Connecticut Children's Medical Center

Who can join

7 and older, any sex, with Sickle Cell Disease. 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.

Number of Participants With Improvement in Pain Scores of >2 Points on the Pain Scale Primary · Baseline then daily while inpatient, up to 72 hours

Determine if there is an apparent improvement in pain control with the ketamine infusion based on the investigator's discretion and comparison to past pain scores. Pain was scored on a scale from 0 to 10. Zero equaled no pain and 10 equaled a lot of pain.

Group	Value	95% CI
Ketamine	3

Number of Participants Who Showed a Reduction of Opioid Utilization While on IV Ketamine Secondary · Baseline then daily while inpatient, up to 72 hours

Looking at the reduction of opioid utilization while on IV Ketamine. Three participants were enrolled in the study, therefore a comprehensive analysis could not be done due to the low enrollment.

Group	Value	95% CI
Ketamine	3

Sponsor's own description

Acute pain episodes associated with sickle cell disease (SCD) are very difficult to manage effectively. Opioid tolerance and side effects have been major roadblocks in our ability to provide these patients with adequate pain relief. This pilot study is designed to examine the safety and feasibility of using ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, in the inpatient seeing with children and adolescents who have sickle cell vasoocclusive pain. Previous research suggests that in subanesthetic doses, ketamine may be able to prevent the development of opiate tolerance and facilitate better pain relief with lower opiate doses, allowing for less respiratory depression, less sedation, easier ambulation, less deconditioning, shorter hospital stays, and better quality of life. The goal of this pilot study is to evaluate the safety and feasibility of using a continuous infusion of ketamine, in conjunction with opiates, in the inpatient setting for sickle cell vasoocclusive pain. It is hypothesized that using a low dose ketamine infusion in conjunction with opiates will be a safe and feasible practice for the treatment of sickle cell pain.

Publications & conference data

1 peer-reviewed publication 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