Ketamine for Sickle Cell Disease

NA
Overseen ByNatasha Archer, MD, MPH
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: Boston Children's Hospital
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether early administration of ketamine (an anesthetic) can reduce hospital admissions for individuals with sickle cell disease experiencing pain. Researchers aim to determine if starting ketamine within one hour of emergency department arrival can decrease the need for hospital stays. If admission occurs, the trial also examines whether early ketamine use can reduce opioid consumption and shorten hospital stays. Suitable participants have sickle cell disease, frequently visit the emergency department due to pain, and are between 6 and 24 years old. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ketamine is likely to be safe for humans?

Research has shown that ketamine is generally safe for managing pain in people with sickle cell disease. Studies have found that low doses of ketamine, which do not cause a full-body reaction, are well-tolerated by both adults and children. In these cases, ketamine reduced pain and often decreased the need for opioids, which are strong pain-relief drugs.

One study found that ketamine managed pain from sickle cell crises without causing major side effects. Another review suggested that ketamine can be used safely and effectively, especially when given in doses that do not cause feelings of disconnection from reality.

In summary, current research supports ketamine as a safe option for pain relief in sickle cell disease patients, with a record of reducing pain and minimizing opioid use.12345

Why do researchers think this study treatment might be promising for sickle cell disease?

Researchers are excited about using ketamine for sickle cell disease because it offers a new approach compared to standard treatments like hydroxyurea and blood transfusions. Ketamine works differently by potentially targeting pain pathways directly, offering rapid pain relief, which is crucial for managing the severe pain crises associated with sickle cell disease. Additionally, this trial uses a single oral dose of ketamine, which could simplify administration and make it more accessible for patients compared to intravenous options.

What evidence suggests that ketamine might be an effective treatment for sickle cell disease?

Research has shown that ketamine might help manage pain for people with sickle cell disease. Studies have found that ketamine can reduce pain as effectively as opioids during painful episodes. Some research also suggests that ketamine can lessen the need for opioids, potentially leading to fewer side effects. In this trial, participants will receive either a single dose of oral ketamine or a placebo. Administering ketamine early has been linked to lower pain levels and reduced opioid use. Overall, evidence supports ketamine as a promising option for managing pain in patients with sickle cell disease.12367

Who Is on the Research Team?

NA

Natasha Archer

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 6 to 24 with sickle cell disease who come to the emergency department or clinic because of pain. People can't join if they have severe side effects from ketamine, are allergic to it, or can't give consent.

Inclusion Criteria

Patient at study site
I am currently experiencing pain and have come to the emergency room or infusion clinic.
I am between 6 and 24 years old.
See 1 more

Exclusion Criteria

I have had severe side effects from ketamine.
Allergy to ketamine
I am not able to give my own consent for medical decisions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive a single dose of oral ketamine or placebo within 1 hour of acute care presentation

1 day
1 visit (in-person)

Hospital Admission and Open-label Treatment

If admitted, participants may start open-label IV ketamine upon admission to the floor based on clinical needs

Up to 30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including readmission rates and satisfaction surveys

14 days post discharge

What Are the Treatments Tested in This Trial?

Interventions

  • Ketamine

Trial Overview

The study compares giving ketamine by mouth within one hour of arrival versus a placebo in patients with sickle cell disease pain. It looks at whether early ketamine reduces hospital admissions and opioid use compared to starting it later.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Oral KetamineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

Citations

Safety and efficacy of ketamine use in patients with vaso ...

Ketamine qualitative synthesis shows potential for improving pain management in SCD patients during VOC, but without statistically significant differences in ...

Ketamine for Sickle Cell Vaso-Occlusive Crises - PMC - NIH

This systematic review showed that ketamine has a potentially comparable efficacy with other opioids in reducing pain during VOC in SCD patients. However, in ...

Increasing ketamine administration in children's hospitals for ...

The growing evidence that ketamine may provide an effective, opioid-sparing option for pain control for patients with SCD might contribute to ...

Ketamine Effectiveness in Sickle Cell Disease (SCD) Vaso- ...

An assessment of the use, perceived benefits, and outcomes of ketamine in sickle cell vaso-occlusive crisis in the United States. ... Oral ketamine for sickle ...

Subdissociative-dose ketamine for sickle cell vaso- ...

Overall, the studies discussed in this review show decreased opioid use when subdissociative ketamine is provided as an adjunct and resolution ...

Ketamine for Pain in Sickle Cell Disease Reduces Opioid ...

In pediatric patients with SCD, subanesthetic ketamine was safe as a continuous infusion and effectively reduced both pain scores and opioid requirements.

What evidence supports the use of ketamine in pain ...

Among the literature in SCD, only one study evaluated oral administration of ketamine in a single adult patient at a dose of 15 mg every 6 hours ...