Clinical trial NCT02573714: Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Ketamine
Intranasal
Pain crisis
Vasoocclusive Pain
Sickle cell disease
Lead sponsor: Cameroon Baptist Convention Health
Sponsor class: OTHER
Collaborators: name: Carolinas Medical Center
name: Muhimbili National Hospital
First posted: 2015-10-12
Enrollment: 160
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a randomized, placebo-controlled, drug trial using sub-dissociative intranasal ketamine as an adjunct to standard pharmacotherapy for the management of pediatric sickle cell disease vasoocclusive pain crises in resource-poor settings. Pediatric patients will be enrolled at a teaching and referral hospital in West Africa. Patients will be randomly assigned to the treatment arm - standard therapy plus sub-dissociative intranasal ketamine (1 mg/kg) given at time zero) or the control arm - standard therapy plus intranasal normal saline (volume-matched to treatment arm), and patients will evaluated at standard intervals to assess for pain scores and vital signs (0 minutes, 30 minutes, 60 minutes, and 120 minutes). Pain will be assessed using the Faces Pain Scale - Revised (FPS-R). Patients will also be observed for any potential side effects or adverse events. All patients will be contacted 2-3 weeks post intranasal medication administration for over-the-phone follow-up using a portion of the PedsQL-SCD questionnaire, to assess for basic quality of life related to pain management and treatment.

Eligibility 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

Primary outcomes:
measure: Change from Baseline (time zero) in FPS-R scores between treatment groups
timeFrame: Baseline (time zero, indicated by injection of intranasal medication), 30 minutes, 60 minutes, and 120 minutes
Secondary outcomes:
measure: Hospital length of stay
timeFrame: through study completion, an average of 3 days
measure: Quality of life assessment (PedsQL-SCD Module scores)
timeFrame: Time of first intranasal administration to 3 weeks post intranasal intervention.
measure: Analgesia use - paracetamol
timeFrame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration
measure: Analgesia use - ibuprofen
timeFrame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration
measure: Analgesia use - opioids
timeFrame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration
Other outcomes:
measure: Adverse Events
timeFrame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration
measure: Serious Adverse Events
timeFrame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration
Locations:
city: Bamenda
country: Cameroon
facility: Mbingo Baptist Hospital
state: Northwest Province
city: Dar es Salam
country: Tanzania
facility: Muhimbili National Hospital
Study officials:
affiliation: Cameroon Baptist Convention Health
name: Ernest Nshom, MD
role: STUDY_DIRECTOR
affiliation: Carolinas Medical Center
name: Michael Runyon, MD
role: STUDY_CHAIR
affiliation: Carolinas Medical Center
name: James R Young, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolinas Medical Center
name: Stacy Reynolds, MD
role: STUDY_DIRECTOR
affiliation: Muhimbili University of Health and Allied Sciences
name: Hendry R Sawe, MD
role: STUDY_DIRECTOR
affiliation: Mihumbili National Hospital
name: Juma Mfinanga, MD
role: STUDY_DIRECTOR
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