Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02573714
• Date of registration: 08/10/2015
• Prospective Registration: Yes
• Primary sponsor: Cameroon Baptist Convention Health
• Public title: Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises
• Scientific title: Comparison of Sub-dissociative Intranasal Ketamine Plus Standard Pain Therapy Versus Standard Pain Therapy in the Treatment of Pediatric Sickle Cell Disease Vasoocclusive Crises in Resource-limited Settings: a Multi-centered, Randomized, Controlled Trial
• Date of first enrolment: December 2015
• Target sample size: 160
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02573714
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

Cameroon, Tanzania

Contacts

• Name: Stacy Reynolds, MD
• Affiliation: Carolinas Medical Center

• Name: Michael Runyon, MD
• Affiliation: Carolinas Medical Center

• Name: James R Young, MD
• Affiliation: Carolinas Medical Center

• Name: James R Young, MD

• Name: Hendry R Sawe, MD
• Affiliation: Muhimbili University of Health and Allied Sciences

• Name: Ernest Nshom, MD
• Affiliation: Cameroon Baptist Convention Health

• Name: Juma Mfinanga, MD
• Affiliation: Mihumbili National Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Sickle cell disease (SCD)

- Vasoocclusive pain crisis

- Requiring analgesia

Exclusion Criteria:

- Anatomic variations of nose precluding intranasal medication administration

- Ketamine allergy

- Non-verbal

- Obtunded

- Pregnant

- Other acute SCD complications:

- Acute chest syndrome

- Sepsis

- Stroke

- Splenic sequestration

- Pulmonary embolism

- Acute osteomyelitis



Age minimum: 4 Years
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sickle Cell Disease

Intervention(s)

Other: Faces Pain Scale - Revised

Other: Pediatric Quality of Life - Sickle Cell Disease Module

Drug: Ketamine

Drug: Normal Saline

Other: Standard Pain Therapy

Primary Outcome(s)

Change from Baseline (time zero) in FPS-R scores between treatment groups [Time Frame: Baseline (time zero, indicated by injection of intranasal medication), 30 minutes, 60 minutes, and 120 minutes]

Secondary Outcome(s)

Hospital length of stay [Time Frame: through study completion, an average of 3 days]

Quality of life assessment (PedsQL-SCD Module scores) [Time Frame: Time of first intranasal administration to 3 weeks post intranasal intervention.]

Analgesia use - ibuprofen [Time Frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration]

Analgesia use - paracetamol [Time Frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration]

Analgesia use - opioids [Time Frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration]

Secondary ID(s)

NIMR/HQ/R.8a/Vol. IX/2299

TFDA0015/CTR/0015/9

IRB2015-07

MNH/IRB/I/2015/14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Muhimbili National Hospital

Carolinas Medical Center