NCT03502421: SCD

Ketamine Sickle Cell Disease

Withdrawn Phase 3 Last updated 26 September 2018

What this trial tests

Phase 3 trial testing Ketamine in SC Disease. Withdrawn.

Timeline

1 September 2018

Primary endpoint
1 September 2019

1 November 2019

Quick facts

Lead sponsor	University of South Florida
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 September 2018
Primary completion	1 September 2019
Estimated completion	1 November 2019

Drugs / interventions tested

• Ketamine (ketamine) — full drug profile →

Conditions studied

• SC Disease — all drugs for SC Disease →
• Pain, Chronic — all drugs for Pain, Chronic →

Sponsor

University of South Florida

Who can join

18 and older, any sex, with SC Disease or Pain, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sickle cell disease (SCD) often results in acute vaso-occlusive crisis (VOC), an obstruction of blood vessels resulting in ischemic injury and pain. The pain experienced during these episodes is due to a wide range of pathophysiological processes. Though recent studies have begun to unravel the underlying mechanisms of these processes, literature focused on pain management for sickle cell disease is scarce. Opioids and non-steroidal anti-inflammatory drugs (NSAIDs) remain the predominate treatment for VOC.

However, the efficacy of these treatments has come into question. A large sub-set of patients with SCD report continued pain despite treatment with opioids. Tolerance and opioid-induced hyperalgesia (OIH) may be responsible for unresponsiveness to opioid-centric treatment modalities. New classes of drugs are being tested to prevent and treat acute pain associated with SCD, but in the meantime physicians are looking to existing therapies to bridge the gap.

The N-methyl-d-aspartate (NMDA) receptor has been implicated in both tolerance and OIH. As a NMDA receptor agonist, ketamine has been shown to modulate opioid tolerance and OIH in animal models and clinical settings. Ketamine utilized as a low dose continuous infusion could benefit patients with SCD related pain that are unresponsive to opioid analgesics. Based on limited studies of adjuvant ketamine use for pain management, low-dose ketamine continuous infusion appears safe. Further clinical investigations are warranted to fully support the use of low-dose ketamine infusion in patients with SCD-related pain.

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. Commonly used agent for acute pain management of sickle cell anemia in Saudi Emergency Department: A narrative review.
   Hejazi RA, Mandourah NA, Alsulami AS, Bakhsh HT, et al · · 2021 · cited 7× · PMID 34194255 · DOI 10.1016/j.jsps.2021.02.001