RightFit
Not yet recruitingPhase 3

Optimal Timing of Ketamine Initiation for SCD Pain

Double-blind, Randomized, Placebo Controlled Study to Evaluate Optimal Timing of Ketamine Initiation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 24 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether giving ketamine, a pain medicine, within 1 hour of arriving for care lowers the chance of a hospital stay. It is for people ages 6 to 24 with sickle cell disease who come in with pain. For those admitted, it also looks at whether starting ketamine early reduces the need for opioid pain medicines or shortens the hospital stay.

The goal of this clinical trial is to learn if the use of early ketamine decreases the chance of admission to the hospital in patients with sickle cell disease presenting with pain. The main questions this study aims to answer are: * Does ketamine given within 1 hour of acute care presentation decrease the chance of hospital admission? * If admitted, does continuing ketamine in the first few hours of admission decrease opioid use or length of stay compared to those who start it later in the admission? Researchers will compare the study arm to patients with sickle cell disease who receive placebo within 1 hour of presentation for the first aim. Participants will be given ketamine/placebo by mouth without 1 hour of presentation. If admitted, all participants will be able to start open label IV ketamine upon admission to the floor based on their clinical needs. Participants who end up starting ketamine will be reviewed to determine if early start to ketamine is helpful in reducing opioid use and length of stay.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have sickle cell disease.
  • Come to the emergency department or infusion clinic with pain.
  • Be a patient at the study site.
  • Be 6 to 24 years old.

Who can't join

  • Have an allergy to ketamine.
  • Have severe side effects linked to ketamine.
  • Be unable to give consent, or permission, to join the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * sickle cell disease diagnosis * presenting with pain to ED or infusion clinic * patient at study site * 6 to 24 years old Exclusion Criteria: * allergy to ketamine * severe side effects associated with ketamine * unable to consent

Study sites (1)

MA