CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Ketaminedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03296345
NCT03296345Phase 2Completed

Adjuvant Low-dose Ketamine in Pediatric Sickle Cell Vaso-occlusive Crisis (AKTSS)

UCSF Benioff Children's Hospital Oakland·interventional·Posted Sep 28, 2017·Updated Apr 20, 2021

In Brief

A Phase 2 clinical trial evaluating Ketamine for Sickle Cell Disease and Vaso-Occlusive Crisis. Completed, enrolled 62 participants across 1 site.

Detailed Summary

Acute vaso-occlusive episodes (VOEs) in sickle cell disease (SCD) are primarily managed with opioids. Tolerance and hyperalgesia to opioids develops due to N-methyl-D-aspartate (NMDA)-receptor mediated activation of the nociceptive system, and as a receptor antagonist, ketamine mitigates this. Intravenous (IV) ketamine has demonstrated efficacy in reducing post-operative, chronic, and cancer-related pain in pediatrics, as well as in reducing time to pain control in the emergency department (ED) in adults. Limited studies suggest efficacy in adult opioid-refractory SCD patients. This study is investigating the safety and tolerability of adjuvant low-dose IV ketamine bolus for pediatric SCD VOE in the ED, as well as its efficacy in improving pain control and reducing hospitalization.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 28, 2017
Enrollment StartJun 1, 2016
Primary CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.8 years ago

Interventions

Ketaminedrug

The intervention is IV low-dose bolus ketamine as an adjuvant to standard therapy (IV opiates and NSAIDs).