Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises

Summary

The purpose of this study is to determine if the use of ketamine, sniffed in the nose, is a safe and effective way to help reduce pain in pediatric sickle cell patients with pain crises in resource-limited settings.

Conditions

• Sickle Cell Disease

Interventions

DRUG

Normal Saline

Intranasal normal saline (placebo: volume-matched with intranasal ketamine) will be given at time zero. Intranasal administration will be performed by placing the needleless syringe gently into the nares with the patient sitting upright. Volumes of ≤ 0.75ml will be nasally inhaled in a single nare, while volumes \> 0.75ml will be divided between both nares. Patients who are unable to inhale the medication nasally will receive drip administration of the same volume while recumbent on the bed.

OTHER

Standard Pain Therapy

Typical management strategy for pediatric sickle cell disease vasoocclusive crises including acetaminophen/paracetamol, ibuprofen, oral opioids, and injectable opioids depending on pain severity.

OTHER

Pediatric Quality of Life - Sickle Cell Disease Module

Standardized quality of life assessment performed 2-3 weeks post intranasal medication administration to evaluate pain management and severity of symptoms after discharge from the hospital.

OTHER

Faces Pain Scale - Revised

All patients will answer the FPS-R at 0 minutes (immediately prior to receiving intranasal medication), 30 minutes, 60 minutes, and 120 minutes to assess current pain status.

DRUG

Ketamine

Intranasal ketamine (concentration: 50 mg/ml, dose: 1 mg/kg) will be given at time zero. Intranasal administration will be performed by placing the needleless syringe gently into the nares with the patient sitting upright. Volumes of ≤ 0.75ml will be nasally inhaled in a single nare, while volumes \> 0.75ml will be divided between both nares. Patients who are unable to inhale the medication nasally will receive drip administration of the same volume while recumbent on the bed.

Sponsors & Collaborators

• Carolinas Medical Center

  collaborator OTHER

• Muhimbili National Hospital

  collaborator UNKNOWN

• Cameroon Baptist Convention Health

  lead OTHER

Principal Investigators

• Ernest Nshom, MD · Cameroon Baptist Convention Health

• Michael Runyon, MD · Carolinas Medical Center

• James R Young, MD · Carolinas Medical Center

• Stacy Reynolds, MD · Carolinas Medical Center

• Hendry R Sawe, MD · Muhimbili University of Health and Allied Sciences

• Juma Mfinanga, MD · Mihumbili National Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-31

Primary Completion

2019-07-31

Completion

2019-07-31

Countries

• Cameroon
• Tanzania

Study Locations