Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises

NAUnknownINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

July 31, 2019

Study Completion Date

July 31, 2019

Conditions
Sickle Cell Disease
Interventions
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.

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.

Trial Locations (2)

Unknown

RECRUITING

Mbingo Baptist Hospital, Bamenda

NOT_YET_RECRUITING

Muhimbili National Hospital, Dar es Salaam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Carolinas Medical Center

OTHER

collaborator

Muhimbili National Hospital

UNKNOWN

lead

Cameroon Baptist Convention Health

OTHER

NCT02573714 - Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises | Biotech Hunter | Biotech Hunter