Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises

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ClinicalTrials.gov Identifier: NCT02573714

Recruitment Status : Unknown

Verified March 2019 by Cameroon Baptist Convention Health.
Recruitment status was: Recruiting

First Posted : October 12, 2015

Last Update Posted : March 14, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Carolinas Medical Center

Muhimbili National Hospital

Information provided by (Responsible Party):

Cameroon Baptist Convention Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sickle Cell Disease	Drug: Ketamine Drug: Normal Saline Other: Standard Pain Therapy Other: Pediatric Quality of Life - Sickle Cell Disease Module Other: Faces Pain Scale - Revised	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	160 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
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 Start Date :	December 2015
Estimated Primary Completion Date :	July 2019
Estimated Study Completion Date :	July 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Sickle cell disease

Drug Information available for: Ketamine

Genetic and Rare Diseases Information Center resources: Sickle Cell Anemia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: 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. Other: 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. Other: 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. Other Name: PedsQL-SCD Other: 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 Name: FPS-R
Placebo Comparator: 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.	Drug: 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. Other Name: NaCl 0.9% Other: 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. Other: 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. Other Name: PedsQL-SCD Other: 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 Name: FPS-R

Arm

Intervention/treatment

Experimental: 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.

Drug: 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.

Other: 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.

Other: 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.

Other Name: PedsQL-SCD

Other: 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 Name: FPS-R

Placebo Comparator: 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.

Drug: 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.

Other Name: NaCl 0.9%

Other: 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.

Other: 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.

Other Name: PedsQL-SCD

Other: 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 Name: FPS-R

Outcome Measures

Primary Outcome Measures :

Change from Baseline (time zero) in FPS-R scores between treatment groups [ Time Frame: 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 :

Hospital length of stay [ Time Frame: 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 Frame: 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 Frame: 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 Frame: 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 Frame: 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 Outcome Measures:

Adverse Events [ Time Frame: 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 Frame: 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	4 Years to 16 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573714

Contacts

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Contact: James R Young, MD	704-578-5078	james.young@carolinashealthcare.org

Locations

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Cameroon
Mbingo Baptist Hospital	Recruiting
Bamenda, Northwest Province, Cameroon
Contact: James R Young, MD 704-578-5078 james.young@carolinashealthcare.org
Contact: Ernest Nshom, MD
Sub-Investigator: Ethan Helm, MD
Principal Investigator: Ernest Nshom, MD
Tanzania
Muhimbili National Hospital	Not yet recruiting
Dar es Salam, Tanzania
Contact: Hendry R Sawe, MD Hendry_sawe@yahoo.com
Contact: Juma Mfinanga, MD jumamfinanga@gmail.com
Principal Investigator: Hendry R Sawe, MD
Sub-Investigator: Juma Mfinanga, MD

Sponsors and Collaborators

Cameroon Baptist Convention Health

Carolinas Medical Center

Muhimbili National Hospital

Investigators

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Study Director:	Ernest Nshom, MD	Cameroon Baptist Convention Health
Study Chair:	Michael Runyon, MD	Carolinas Medical Center
Principal Investigator:	James R Young, MD	Carolinas Medical Center
Study Director:	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

More Information

Publications:

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Gill FM, Sleeper LA, Weiner SJ, Brown AK, Bellevue R, Grover R, Pegelow CH, Vichinsky E. Clinical events in the first decade in a cohort of infants with sickle cell disease. Cooperative Study of Sickle Cell Disease. Blood. 1995 Jul 15;86(2):776-83.

Olabode JO, Shokunbi WA. Types of crises in sickle cell disease patients presenting at the haematology day care unit (HDCU), University College Hospital (UCH), Ibadan. West Afr J Med. 2006 Oct-Dec;25(4):284-8.

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GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Jan 10;385(9963):117-71. doi: 10.1016/S0140-6736(14)61682-2. Epub 2014 Dec 18.

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Smith DC, Mader TJ, Smithline HA. Low dose intravenous ketamine as an analgesic: a pilot study using an experimental model of acute pain. Am J Emerg Med. 2001 Oct;19(6):531-2. doi: 10.1053/ajem.2001.27152. No abstract available.

Graudins A, Meek R, Egerton-Warburton D, Oakley E, Seith R. The PICHFORK (Pain in Children Fentanyl or Ketamine) trial: a randomized controlled trial comparing intranasal ketamine and fentanyl for the relief of moderate to severe pain in children with limb injuries. Ann Emerg Med. 2015 Mar;65(3):248-254.e1. doi: 10.1016/j.annemergmed.2014.09.024. Epub 2014 Nov 18.

Fu ES, Miguel R, Scharf JE. Preemptive ketamine decreases postoperative narcotic requirements in patients undergoing abdominal surgery. Anesth Analg. 1997 May;84(5):1086-90. doi: 10.1097/00000539-199705000-00024.

Nesher N, Ekstein MP, Paz Y, Marouani N, Chazan S, Weinbroum AA. Morphine with adjuvant ketamine vs higher dose of morphine alone for immediate postthoracotomy analgesia. Chest. 2009 Jul;136(1):245-252. doi: 10.1378/chest.08-0246. Epub 2008 Aug 27.

Wolfe TR, Braude DA. Intranasal medication delivery for children: a brief review and update. Pediatrics. 2010 Sep;126(3):532-7. doi: 10.1542/peds.2010-0616. Epub 2010 Aug 9.

Pandey RK, Bahetwar SK, Saksena AK, Chandra G. A comparative evaluation of drops versus atomized administration of intranasal ketamine for the procedural sedation of young uncooperative pediatric dental patients: a prospective crossover trial. J Clin Pediatr Dent. 2011 Fall;36(1):79-84. doi: 10.17796/jcpd.36.1.1774746504g28656.

Donnelly RF. Stability of diluted ketamine packaged in glass vials. Can J Hosp Pharm. 2013 May;66(3):198. doi: 10.4212/cjhp.v66i3.1259. No abstract available.

Walker SE, Law S, DeAngelis C. Stability and compatibility of hydromorphone and ketamine in normal saline. Can J Hosp Pharm. 2001;54(3):191-199.

Arya R, Gulati S, Kabra M, Sahu JK, Kalra V. Intranasal versus intravenous lorazepam for control of acute seizures in children: a randomized open-label study. Epilepsia. 2011 Apr;52(4):788-93. doi: 10.1111/j.1528-1167.2010.02949.x. Epub 2011 Jan 28.

Borland M, Jacobs I, King B, O'Brien D. A randomized controlled trial comparing intranasal fentanyl to intravenous morphine for managing acute pain in children in the emergency department. Ann Emerg Med. 2007 Mar;49(3):335-40. doi: 10.1016/j.annemergmed.2006.06.016. Epub 2006 Oct 25.

Tayebati SK, Nwankwo IE, Amenta F. Intranasal drug delivery to the central nervous system: present status and future outlook. Curr Pharm Des. 2013;19(3):510-26.

Pires A, Fortuna A, Alves G, Falcao A. Intranasal drug delivery: how, why and what for? J Pharm Pharm Sci. 2009;12(3):288-311. doi: 10.18433/j3nc79.

Green SM, Roback MG, Krauss B, Brown L, McGlone RG, Agrawal D, McKee M, Weiss M, Pitetti RD, Hostetler MA, Wathen JE, Treston G, Garcia Pena BM, Gerber AC, Losek JD; Emergency Department Ketamine Meta-Analysis Study Group. Predictors of airway and respiratory adverse events with ketamine sedation in the emergency department: an individual-patient data meta-analysis of 8,282 children. Ann Emerg Med. 2009 Aug;54(2):158-68.e1-4. doi: 10.1016/j.annemergmed.2008.12.011. Epub 2009 Feb 7.

Yanagihara Y, Ohtani M, Kariya S, Uchino K, Hiraishi T, Ashizawa N, Aoyama T, Yamamura Y, Yamada Y, Iga T. Plasma concentration profiles of ketamine and norketamine after administration of various ketamine preparations to healthy Japanese volunteers. Biopharm Drug Dispos. 2003 Jan;24(1):37-43. doi: 10.1002/bdd.336.

Malinovsky JM, Servin F, Cozian A, Lepage JY, Pinaud M. Ketamine and norketamine plasma concentrations after i.v., nasal and rectal administration in children. Br J Anaesth. 1996 Aug;77(2):203-7. doi: 10.1093/bja/77.2.203.

Tsze DS, Steele DW, Machan JT, Akhlaghi F, Linakis JG. Intranasal ketamine for procedural sedation in pediatric laceration repair: a preliminary report. Pediatr Emerg Care. 2012 Aug;28(8):767-70. doi: 10.1097/PEC.0b013e3182624935.

Herd DW, Anderson BJ, Keene NA, Holford NH. Investigating the pharmacodynamics of ketamine in children. Paediatr Anaesth. 2008 Jan;18(1):36-42. doi: 10.1111/j.1460-9592.2007.02384.x.

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Ambe JP, Mava Y, Chama R, Farouq G, Machoko Y. Clinical features of sickle cell anaemia in northern nigerian children. West Afr J Med. 2012 Apr-Jun;31(2):81-5.

Piel FB, Hay SI, Gupta S, Weatherall DJ, Williams TN. Global burden of sickle cell anaemia in children under five, 2010-2050: modelling based on demographics, excess mortality, and interventions. PLoS Med. 2013;10(7):e1001484. doi: 10.1371/journal.pmed.1001484. Epub 2013 Jul 16.

Aloni MN, Nkee L. Challenge of managing sickle cell disease in a pediatric population living in kinshasa, democratic republic of congo: a sickle cell center experience. Hemoglobin. 2014;38(3):196-200. doi: 10.3109/03630269.2014.896810. Epub 2014 Mar 26.

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Andolfatto G, Willman E, Joo D, Miller P, Wong WB, Koehn M, Dobson R, Angus E, Moadebi S. Intranasal ketamine for analgesia in the emergency department: a prospective observational series. Acad Emerg Med. 2013 Oct;20(10):1050-4. doi: 10.1111/acem.12229.

Nielsen BN, Friis SM, Romsing J, Schmiegelow K, Anderson BJ, Ferreiros N, Labocha S, Henneberg SW. Intranasal sufentanil/ketamine analgesia in children. Paediatr Anaesth. 2014 Feb;24(2):170-80. doi: 10.1111/pan.12268. Epub 2013 Oct 1.

Palermo TM, Riley CA, Mitchell BA. Daily functioning and quality of life in children with sickle cell disease pain: relationship with family and neighborhood socioeconomic distress. J Pain. 2008 Sep;9(9):833-40. doi: 10.1016/j.jpain.2008.04.002. Epub 2008 Jun 12.

PedsQL Sickle Cell Disease Module, Version 3.0. 1998 JW Varni, Ph.D. (http://www.proqolid.org/instruments/pediatric_quality_of_life_inventory_sickle_cell_disease_module_pedsql_sickle_cell_disease_module)

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World Health Organisation, "Sickle cell anaemia. Agenda item 11.4," in 59th World Health Assembly, 27 May 2006, World Health Organisation, Geneva, Switzerland, 2006.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Cameroon Baptist Convention Health
ClinicalTrials.gov Identifier:	NCT02573714
Other Study ID Numbers:	IRB2015-07 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 )
First Posted:	October 12, 2015 Key Record Dates
Last Update Posted:	March 14, 2019
Last Verified:	March 2019

Keywords provided by Cameroon Baptist Convention Health:


Ketamine Intranasal Pain crisis Vasoocclusive Pain Sickle cell disease

Additional relevant MeSH terms:

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Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Ketamine Analgesics Sensory System Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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