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| ID | Type | Description | Link |
|---|---|---|---|
| MNH/IRB/I/2015/14 | Other Identifier | Muhimbili National Hospital IRB | |
| TFDA0015/CTR/0015/9 | Other Identifier | Tanzania Food and Drugs Authority | |
| NIMR/HQ/R.8a/Vol. IX/2299 | Other Identifier | Tanzania National Institute for Medical Research |
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| Name | Class |
|---|---|
| Carolinas Medical Center | OTHER |
| Muhimbili National Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Ketamine | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline (time zero) in FPS-R scores between treatment groups | Measure of differences of change of FPS-R scores from baseline to 30 minutes, 60 minutes, and 120 minutes compared between treatment arms | Baseline (time zero, indicated by injection of intranasal medication), 30 minutes, 60 minutes, and 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay | Hospital length of stay recorded from time zero to time of discharge documented by the study clinician will be a secondary outcome measure. | through study completion, an average of 3 days |
| Quality of life assessment (PedsQL-SCD Module scores) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events include: bad taste is mouth, drowsiness, dizziness, itchy nose, nausea, dysphoria, and other novel subjective negative experiences | Time of initial intranasal drug administration to 2 hours post intranasal drug administration |
| Serious Adverse Events |
Inclusion Criteria:
Exclusion Criteria:
Anatomic variations of nose precluding intranasal medication administration
Ketamine allergy
Non-verbal
Obtunded
Pregnant
Other acute SCD complications:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James R Young, MD | Contact | 704-578-5078 | james.young@carolinashealthcare.org |
| Name | Affiliation | Role |
|---|---|---|
| Ernest Nshom, MD | Cameroon Baptist Convention Health | Study Director |
| Michael Runyon, MD | Carolinas Medical Center | Study Chair |
| James R Young, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mbingo Baptist Hospital | Recruiting | Bamenda | Northwest Province | Cameroon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25909112 | Background | Alli NA, Patel M, Alli HD, Bassa F, Coetzee MJ, Davidson A, Essop MR, Lakha A, Louw VJ, Novitzky N, Philip V, Poole JE, Wainwright RD. Recommendations for the management of sickle cell disease in South Africa. S Afr Med J. 2014 Nov;104(11):743-51. doi: 10.7196/samj.8470. | |
| 11844993 | Background | Diallo D, Tchernia G. Sickle cell disease in Africa. Curr Opin Hematol. 2002 Mar;9(2):111-6. doi: 10.1097/00062752-200203000-00005. |
Not provided
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
Not provided
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
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|
| Normal Saline | Drug | 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 | Other | 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 | Other | 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 | Other | 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. |
|
|
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. |
| Time of first intranasal administration to 3 weeks post intranasal intervention. |
| Analgesia use - paracetamol | Individual evaluation of total paracetamol use per kilogram body weight | Time of initial intranasal drug administration to 2 hours post intranasal drug administration |
| Analgesia use - ibuprofen | Individual evaluation of total ibuprofen use per kilogram body weight | Time of initial intranasal drug administration to 2 hours post intranasal drug administration |
| Analgesia use - opioids | Individual evaluation of total opioid use expressed as morphine equivalents per body weight. | 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 |
| Time of initial intranasal drug administration to 2 hours post intranasal drug administration |
| Carolinas Medical Center |
| Principal Investigator |
| Stacy Reynolds, MD | Carolinas Medical Center | Study Director |
| Hendry R Sawe, MD | Muhimbili University of Health and Allied Sciences | Study Director |
| Juma Mfinanga, MD | Mihumbili National Hospital | Study Director |
| Muhimbili National Hospital | Not yet recruiting | Dar es Salaam | Tanzania |
|
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| 28698351 | Derived | Young JR, Sawe HR, Mfinanga JA, Nshom E, Helm E, Moore CG, Runyon MS, Reynolds SL. Subdissociative intranasal ketamine plus standard pain therapy versus standard pain therapy in the treatment of paediatric sickle cell disease vaso-occlusive crises in resource-limited settings: study protocol for a randomised controlled trial. BMJ Open. 2017 Jul 10;7(7):e017190. doi: 10.1136/bmjopen-2017-017190. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |