Sickle Cell Disease
Conditions
Keywords
Ketamine, Intranasal, Pain crisis, Vasoocclusive Pain, Sickle cell disease
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.
Interventions
DRUGKetamine
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.
DRUGNormal 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.
OTHERStandard 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.
OTHERPediatric 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.
OTHERFaces 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.
Sponsors
Carolinas Medical Center
Muhimbili National Hospital
Cameroon Baptist Convention Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 - 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 - ibuprofen | Time of initial intranasal drug administration to 2 hours post intranasal drug administration | Individual evaluation of total ibuprofen 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Time of initial intranasal drug administration to 2 hours post intranasal drug administration | Adverse events include: bad taste is mouth, drowsiness, dizziness, itchy nose, nausea, dysphoria, and other novel subjective negative experiences |
| Serious Adverse Events | Time of initial intranasal drug administration to 2 hours post intranasal drug administration | Serious adverse events include: apnea, assisted ventilation, bradypnea, cyanosis, dissociation, emergence reaction, hypotension, laryngospasm, myoclonus, seizure, and vomiting |
Countries
Cameroon, Tanzania
Contacts
Primary ContactJames R Young, MD
Outcome results
None listed