120 Participants Needed

Ketamine for Sickle Cell Crisis

CL
MS
Overseen ByMohsen Saidinejad, MD
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Mohsen Saidinejad
Must be taking: Opioids
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 explores whether a low dose of ketamine can effectively and safely reduce pain during sickle cell crises in children and young adults. Participants will receive either a low dose of ketamine (administered as a sub-dissociative infusion) alongside traditional pain medicine or only the traditional pain medicine. It targets individuals aged 5-20 with sickle cell disease who are currently experiencing pain crises requiring IV pain relief. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since the study involves adding ketamine to standard pain medicine, it's likely you can continue your current pain treatment.

Is there any evidence suggesting that sub-dissociative ketamine infusion is likely to be safe for children and young adults with sickle cell disease?

Research has shown that using a low dose of ketamine is generally safe for treating pain during sickle cell crises. Studies indicate that, when combined with standard pain medicine like morphine, it can reduce the need for additional opioids. As a result, patients might experience less pain and require fewer doses of stronger drugs.

Low-dose ketamine does not typically cause serious breathing or heart problems, which can occur with other pain treatments. Most people tolerate it well, with few serious side effects reported. These findings suggest that low-dose ketamine is a safe option for managing pain during sickle cell crises.12345

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

Unlike the standard of care for sickle cell crisis, which typically includes pain management with opioids and hydration, sub-dissociative ketamine works differently by targeting the NMDA receptors in the brain. This unique mechanism can provide pain relief without the heavy sedation and potential dependency linked to opioids. Researchers are excited about ketamine because it offers the potential for rapid pain relief and fewer side effects, which could significantly improve the quality of life for patients experiencing a sickle cell crisis.

What evidence suggests that sub-dissociative ketamine infusion might be an effective treatment for sickle cell pain?

Research has shown that a low dose of ketamine might help reduce pain for people with sickle cell disease during a pain crisis. In this trial, participants in one arm will receive a sub-dissociative ketamine infusion. Studies have found that combining ketamine with standard pain medicines like morphine often results in less pain for patients. Ketamine is also associated with a reduced need for opioids, potentially lowering the risk of side effects from these drugs. Some research suggests that ketamine's pain relief could be as effective as opioids. These findings indicate that ketamine could be a promising option for managing pain during sickle cell crises.12678

Are You a Good Fit for This Trial?

This trial is for children and young adults with sickle cell disease who are experiencing pain due to a sickle cell crisis. Participants must be receiving standard opioid treatment for their condition.

Inclusion Criteria

I received pain medication before being asked to join the study.
Primary language is English or Spanish
I am able to give my consent, or if under 18, my parent/guardian can and I can agree if I'm able.
See 3 more

Exclusion Criteria

I have signs of high pressure inside my skull.
Oxygen saturation < 90% on room air
I do not have uncontrolled heart, liver, kidney, or thyroid disease.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either standard of care pain medicine plus a low dose of ketamine or only standard of care pain medicine

Up to 3 days
In-person during ED stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments

4-6 weeks
1 visit (in-person or virtual) at 7-10 days, 1 visit (in-person or virtual) at 4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sub-dissociative Ketamine Infusion

Trial Overview

The study tests if adding a low dose of ketamine to standard opioid pain medication is more effective in managing pain during a sickle cell crisis compared to just the standard treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Sub-dissociative KetamineExperimental Treatment1 Intervention
Group II: Normal SalinePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mohsen Saidinejad

Lead Sponsor

Citations

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

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

232 The Use of Sub-dissociative Ketamine For Sickle Cell ...

The primary outcome of interest was change in patients' reported pain score from baseline to the end of the infusion. Secondary outcomes of interest included ...

Sub-dissociative Dose Ketamine in Treatment of Vaso ...

The purpose of this research is to see if ketamine is effective and safe in treating children and young adults with sickle cell disease ...

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

What evidence supports the use of ketamine in pain management of vaso-occlusive episodes in patients with sickle cell disease?

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

Ketamine has a potentially comparable efficacy with other opioids in reducing the pain during VOC in SCD patients.

Ketamine Infusion for Acute Sickle Cell Crisis in ...

With this study, we wish to explore whether adding ketamine to standard acute opiate therapy (morphine or dilaudid) will decrease subsequent repeat doses of ...

Ketamine administration for acute painful sickle cell crisis - PMC

Primary outcome was mean difference in the numerical pain rating scale (NPRS) score over 2 h. NPRS was recorded every 30 min for a maximum of 180 min and ...

Sub-dissociative Dose Ketamine for Analgesia

Due to its unique pharmacological properties, SDK does not produce many of the potentially adverse respiratory or hemodynamic effects of other analgesics and ...