Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises
NCT ID: NCT02573714
Last Updated: 2019-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2015-12-31
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intranasal 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.
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.
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.
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.
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.
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
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Vasoocclusive pain crisis
* Requiring analgesia
Exclusion Criteria
* Ketamine allergy
* Non-verbal
* Obtunded
* Pregnant
* Other acute SCD complications:
* Acute chest syndrome
* Sepsis
* Stroke
* Splenic sequestration
* Pulmonary embolism
* Acute osteomyelitis
4 Years
16 Years
ALL
No
Sponsors
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Carolinas Medical Center
OTHER
Muhimbili National Hospital
UNKNOWN
Cameroon Baptist Convention Health
OTHER
Responsible Party
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Principal Investigators
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Ernest Nshom, MD
Role: STUDY_DIRECTOR
Cameroon Baptist Convention Health
Michael Runyon, MD
Role: STUDY_CHAIR
Carolinas Medical Center
James R Young, MD
Role: PRINCIPAL_INVESTIGATOR
Carolinas Medical Center
Stacy Reynolds, MD
Role: STUDY_DIRECTOR
Carolinas Medical Center
Hendry R Sawe, MD
Role: STUDY_DIRECTOR
Muhimbili University of Health and Allied Sciences
Juma Mfinanga, MD
Role: STUDY_DIRECTOR
Mihumbili National Hospital
Locations
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Mbingo Baptist Hospital
Bamenda, Northwest Province, Cameroon
Muhimbili National Hospital
Dar es Salaam, , Tanzania
Countries
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Central Contacts
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Facility Contacts
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Ernest Nshom, MD
Role: backup
References
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Other Identifiers
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MNH/IRB/I/2015/14
Identifier Type: OTHER
Identifier Source: secondary_id
TFDA0015/CTR/0015/9
Identifier Type: OTHER
Identifier Source: secondary_id
NIMR/HQ/R.8a/Vol. IX/2299
Identifier Type: OTHER
Identifier Source: secondary_id
IRB2015-07
Identifier Type: -
Identifier Source: org_study_id
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