Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises
- Conditions
- Sickle Cell Disease
- Interventions
- Drug: Normal SalineOther: Standard Pain TherapyOther: Pediatric Quality of Life - Sickle Cell Disease ModuleOther: Faces Pain Scale - Revised
- Registration Number
- NCT02573714
- Lead Sponsor
- Cameroon Baptist Convention Health
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- Sickle cell disease (SCD)
- Vasoocclusive pain crisis
- Requiring analgesia
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intranasal Ketamine Ketamine Patients allocated to receive intranasal ketamine (intervention) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD. Intranasal Ketamine Standard Pain Therapy Patients allocated to receive intranasal ketamine (intervention) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD. Intranasal Ketamine Pediatric Quality of Life - Sickle Cell Disease Module Patients allocated to receive intranasal ketamine (intervention) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD. Intranasal Ketamine Faces Pain Scale - Revised Patients allocated to receive intranasal ketamine (intervention) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD. Normal Saline Normal Saline Patients allocated to receive intranasal normal saline (placebo) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD. Normal Saline Standard Pain Therapy Patients allocated to receive intranasal normal saline (placebo) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD. Normal Saline Pediatric Quality of Life - Sickle Cell Disease Module Patients allocated to receive intranasal normal saline (placebo) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD. Normal Saline Faces Pain Scale - Revised Patients allocated to receive intranasal normal saline (placebo) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.
- Primary Outcome Measures
Name Time Method Change from Baseline (time zero) in FPS-R scores between treatment groups Baseline (time zero, indicated by injection of intranasal medication), 30 minutes, 60 minutes, and 120 minutes Measure of differences of change of FPS-R scores from baseline to 30 minutes, 60 minutes, and 120 minutes compared between treatment arms
- Secondary Outcome Measures
Name Time Method Hospital length of stay through study completion, an average of 3 days Hospital length of stay recorded from time zero to time of discharge documented by the study clinician will be a secondary outcome measure.
Analgesia use - paracetamol Time of initial intranasal drug administration to 2 hours post intranasal drug administration Individual evaluation of total paracetamol use per kilogram body weight
Analgesia use - opioids Time of initial intranasal drug administration to 2 hours post intranasal drug administration Individual evaluation of total opioid use expressed as morphine equivalents per body weight.
Quality of life assessment (PedsQL-SCD Module scores) Time of first intranasal administration to 3 weeks post intranasal intervention. PedsQL-SCD Module scores obtained by study clinicians using over-the-phone interviews between two-three weeks post intervention will be a secondary outcome measure.
Analgesia use - ibuprofen Time of initial intranasal drug administration to 2 hours post intranasal drug administration Individual evaluation of total ibuprofen use per kilogram body weight
Trial Locations
- Locations (2)
Muhimbili National Hospital
🇹🇿Dar es Salam, Tanzania
Mbingo Baptist Hospital
🇨🇲Bamenda, Northwest Province, Cameroon