Optimal Timing of Ketamine Initiation for SCD Pain

ConditionsSickle Cell Disease Sickle Cell Crisis

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age6-24

SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

sickle cell disease diagnosis

presenting with pain to ED or infusion clinic

patient at study site

6 to 24 years old

Disqualifiers

allergy to ketamine

severe side effects associated with ketamine

unable to consent

Trial design

Design model

Parallel

Treatments tested in this trial

Ketamine hydrochloride injection
Drug
The drug will be compounded using Ketamine vial 10mg/ml. Either the participant will take one Listerine strip prior to drinking the ketamine injection solution and one Listerine strip after or the participant will drink a mixture of cherry syrup and ketamine injection solution together.
Placebo
Other intervention
The placebo will be prepared sterile water for a total matching volume of what the ketamine solution would have been. Either the participant will take one Listerine strip prior to drinking the ketamine injection solution and one Listerine strip after or the participant will drink a mixture of cherry syrup and ketamine injection solution together.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Oral KetamineExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Percentage of participants admitted to the hospital from ED or infusion clinic

Investigators will assess the effect of a single dose of oral ketamine compared to placebo administered within one hour of presentation on the percentage of participants admitted to the inpatient hospital unit

Time frame

Within 6 hours of presentation

Secondary outcomes

Scores on brief surveys for satisfaction and side effects

Investigators will assess the participant or guardian's satisfaction with pain treatment experience using a brief 2 question survey. Low scores are worse than high scores (min 0 and max is 5 for each question) 1\. Please rate participant satisfaction with how well the study drug/placebo helped to relieve participant pain. (0 = Very Dissatisfied; 1 = dissatisfied; 2 = somewhat dissatisfied; 3 = somewhat satisfied; 4 = satisfied; 5=Very Satisfied) 2. Please rate how bothersome each of the following side effects were with the drug participant received If participant did not experience a side effect, please select, "Did not experience". (0=Extremely bothersome; 1 = bothersome; 2 = somewhat bothersome; 3 = mildly bothersome; 4 = not bothersome; 5 = Did not experience) Dysphoria, Dizziness, Unpleasant dreams, Hallucinations, Headache, Nausea, Other

Time frame

within 6 hours of receiving study drug/placebo (upon discharge from ED/Infusion)

Numerical Pain Rating Scale Scores

Investigators will assess summed pain intensity difference (SPID) in numerical pain rating scale scores between study drug/placebo. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "worst pain imaginable"). 0 is the best outcome and 10 is the worst outcome.

Time frame

within 6 hours

Other outcomes

Average number of IV opioid administration days in study drug/placebo groups

Investigators will assess the average number of IV opioid administration days in ketamine versus placebo groups

Time frame

30 days of admission

Number of participants readmitted to the hospital within 14 days of discharge from ED, infusion clinic, or inpatient unit.

Investigators will assess clinical outcomes related to discharge including readmission to the ED, infusion clinic, or hospital.

Time frame

Within14 days post discharge

Length of stay of participants admitted when treated with ketamine/placebo

Investigators will assess the length of stay of admitted participants treated with ketamine versus placebo.

Time frame

30 days of admission

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

Source ClinicalTrials.gov

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