Sickle Cell DiseaseNCT02573714
Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises
A study testing Ketamine, Normal Saline and Standard Pain Therapy in people with Sickle Cell Disease, run by Cameroon Baptist Convention Health at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Ketamine, Normal Saline and Standard Pain Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Sickle cell disease (SCD)
- Vasoocclusive pain crisis
- Requiring analgesia
Who cannot join
- Anatomic variations of nose precluding intranasal medication administration
- Ketamine allergy
- Non-verbal
- Obtunded
- Pregnant
- Other acute SCD complications:
Show all 12Show fewer
- Acute chest syndrome
- Sepsis
- Stroke
- Splenic sequestration
- Pulmonary embolism
- Acute osteomyelitis
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Cameroon1 site, 1 recruiting
- Recruiting
Mbingo Baptist Hospital
Bamenda, Northwest Province
James R Young, MD, 704-578-5078, james.young@carolinashealthcare.org
Ernest Nshom, MD
Tanzania1 site, 1 recruiting
- Not yet recruiting
Muhimbili National Hospital
Dar es Salaam
Hendry R Sawe, MD, Hendry_sawe@yahoo.com
Juma Mfinanga, MD, jumamfinanga@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Ketamine, Normal Saline, Standard Pain Therapy, Pediatric Quality of Life - Sickle Cell Disease Module, Faces Pain Scale - Revised
- Keywords
- Ketamine, Intranasal, Pain crisis, Vasoocclusive Pain, Sickle cell disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
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 SalineDrug
Also called NaCl 0.9%
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 TherapyOther
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 ModuleOther
Also called PedsQL-SCD
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 - RevisedOther
Also called FPS-R
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ketamine; Other: Standard Pain Therapy; Other: Pediatric Quality of Life - Sickle Cell Disease Module; Other: Faces Pain Scale - Revised |
| 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. Receives: Drug: Normal Saline; Other: Standard Pain Therapy; Other: Pediatric Quality of Life - Sickle Cell Disease Module; Other: Faces Pain Scale - Revised |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (time zero, indicated by injection of intranasal medication), 30 minutes, 60 minutes, and 120 minutes
Secondary outcomes (5)
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.
Measured: through study completion, an average of 3 days
Quality of life assessment (PedsQL-SCD Module scores)
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.
Measured: Time of first intranasal administration to 3 weeks post intranasal intervention.
Analgesia use - paracetamol
Individual evaluation of total paracetamol use per kilogram body weight
Measured: 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
Measured: 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.
Measured: Time of initial intranasal drug administration to 2 hours post intranasal drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cameroon Baptist Convention Health
- Sponsor type
- University, hospital or other
- Collaborators
- Carolinas Medical Center, Muhimbili National Hospital
- Responsible party
- Sponsor
- Investigators
- Ernest Nshom, MD, Study director, Cameroon Baptist Convention HealthMichael Runyon, MD, Study chair, Carolinas Medical CenterJames R Young, MD, Principal investigator, Carolinas Medical CenterStacy Reynolds, MD, Study director, Carolinas Medical CenterHendry R Sawe, MD, Study director, Muhimbili University of Health and Allied SciencesJuma Mfinanga, MD, Study director, Mihumbili National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573714
- Sponsor's protocol ID
- IRB2015-07
- Other IDs
- MNH/IRB/I/2015/14, TFDA0015/CTR/0015/9, NIMR/HQ/R.8a/Vol. IX/2299
- Status last verified
- Mar 2019
- First submitted
- 8 Oct 2015
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25909112Diallo D, Tchernia G. Sickle cell disease in Africa. Curr Opin Hematol. 2002 Mar;9(2):111-6. doi: 10.1097/00062752-200203000-00005.
PubMed 11844993Platt OS, Thorington BD, Brambilla DJ, Milner PF, Rosse WF, Vichinsky E, Kinney TR. Pain in sickle cell disease. Rates and risk factors. N Engl J Med. 1991 Jul 4;325(1):11-6. doi: 10.1056/NEJM199107043250103.
PubMed 1710777Gill 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.
PubMed 7606007Olabode 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.
PubMed 17402517Quinn CT, Shull EP, Ahmad N, Lee NJ, Rogers ZR, Buchanan GR. Prognostic significance of early vaso-occlusive complications in children with sickle cell anemia. Blood. 2007 Jan 1;109(1):40-5. doi: 10.1182/blood-2006-02-005082. Epub 2006 Aug 29.
PubMed 16940426Ogun GO, Ebili H, Kotila TR. Autopsy findings and pattern of mortality in Nigerian sickle cell disease patients. Pan Afr Med J. 2014 May 8;18:30. doi: 10.11604/pamj.2014.18.30.4043. eCollection 2014.
PubMed 25368719Makani J, Ofori-Acquah SF, Nnodu O, Wonkam A, Ohene-Frempong K. Sickle cell disease: new opportunities and challenges in Africa. ScientificWorldJournal. 2013;2013:193252. doi: 10.1155/2013/193252. Epub 2013 Sep 19.
PubMed 25143960GBD 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.
PubMed 25530442Kohrs R, Durieux ME. Ketamine: teaching an old drug new tricks. Anesth Analg. 1998 Nov;87(5):1186-93. doi: 10.1097/00000539-199811000-00039. No abstract available.
PubMed 9806706Green SM, Clem KJ, Rothrock SG. Ketamine safety profile in the developing world: survey of practitioners. Acad Emerg Med. 1996 Jun;3(6):598-604.
PubMed 8727631Reich DL, Silvay G. Ketamine: an update on the first twenty-five years of clinical experience. Can J Anaesth. 1989 Mar;36(2):186-97. doi: 10.1007/BF03011442.
PubMed 2650898White JM, Ryan CF. Pharmacological properties of ketamine. Drug Alcohol Rev. 1996 Jun;15(2):145-55. doi: 10.1080/09595239600185801.
PubMed 16203365Smith 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.
PubMed 11593484Graudins 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.
PubMed 25447557
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02573714
- Acronym / sponsor ID
- IRB2015-07
- Conditions
- Sickle Cell Disease
- Keywords
- Ketamine, Intranasal, Pain crisis, Vasoocclusive Pain, Sickle cell disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Cameroon Baptist Convention HealthUniversity, hospital or other
- Collaborators
- Carolinas Medical Center, Muhimbili National Hospital
- Study start
- Dec 2015
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Ketamine | Experimental | Drug: Ketamine, Other: Standard Pain Therapy, Other: Pediatric Quality of Life - Sickle Cell Disease Module, Other: Faces Pain Scale - RevisedPatients 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 | Drug: Normal Saline, Other: Standard Pain Therapy, Other: Pediatric Quality of Life - Sickle Cell Disease Module, Other: Faces Pain Scale - RevisedPatients 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. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Sickle cell disease (SCD)
- Vasoocclusive pain crisis
- Requiring analgesia
Key exclusion criteria (12 listed)
- Anatomic variations of nose precluding intranasal medication administration
- Ketamine allergy
- Non-verbal
- Obtunded
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineIntranasal 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. | Drug | Intranasal Ketamine |
| Normal SalineAlso: NaCl 0.9%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. | Drug | Normal Saline |
| Standard Pain TherapyTypical management strategy for pediatric sickle cell disease vasoocclusive crises including acetaminophen/paracetamol, ibuprofen, oral opioids, and injectable opioids depending on pain severity. | Other | Intranasal Ketamine, Normal Saline |
| Pediatric Quality of Life - Sickle Cell Disease ModuleAlso: PedsQL-SCDStandardized 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 | Intranasal Ketamine, Normal Saline |
| Faces Pain Scale - RevisedAlso: FPS-RAll 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 | Intranasal Ketamine, Normal Saline |
Primary outcome
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
5 secondary outcomes
Hospital length of stay
Time frame: through study completion, an average of 3 days
Quality of life assessment (PedsQL-SCD Module scores)
Time frame: Time of first intranasal administration to 3 weeks post intranasal intervention.
Analgesia use - paracetamol
Time frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration
Analgesia use - ibuprofen
Time frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration
Analgesia use - opioids
Time frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Background: PubMed 25909112Alli 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.
- Background: PubMed 11844993Diallo D, Tchernia G. Sickle cell disease in Africa. Curr Opin Hematol. 2002 Mar;9(2):111-6. doi: 10.1097/00062752-200203000-00005.
- Background: PubMed 1710777Platt OS, Thorington BD, Brambilla DJ, Milner PF, Rosse WF, Vichinsky E, Kinney TR. Pain in sickle cell disease. Rates and risk factors. N Engl J Med. 1991 Jul 4;325(1):11-6. doi: 10.1056/NEJM199107043250103.
- Background: PubMed 7606007Gill 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.
- Background: PubMed 17402517Olabode 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.
- Background: PubMed 16940426Quinn CT, Shull EP, Ahmad N, Lee NJ, Rogers ZR, Buchanan GR. Prognostic significance of early vaso-occlusive complications in children with sickle cell anemia. Blood. 2007 Jan 1;109(1):40-5. doi: 10.1182/blood-2006-02-005082. Epub 2006 Aug 29.
- Background: PubMed 25368719Ogun GO, Ebili H, Kotila TR. Autopsy findings and pattern of mortality in Nigerian sickle cell disease patients. Pan Afr Med J. 2014 May 8;18:30. doi: 10.11604/pamj.2014.18.30.4043. eCollection 2014.
- Background: PubMed 25143960Makani J, Ofori-Acquah SF, Nnodu O, Wonkam A, Ohene-Frempong K. Sickle cell disease: new opportunities and challenges in Africa. ScientificWorldJournal. 2013;2013:193252. doi: 10.1155/2013/193252. Epub 2013 Sep 19.
- Background: PubMed 25530442GBD 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.
- Background: PubMed 9806706Kohrs R, Durieux ME. Ketamine: teaching an old drug new tricks. Anesth Analg. 1998 Nov;87(5):1186-93. doi: 10.1097/00000539-199811000-00039. No abstract available.
- Background: PubMed 8727631Green SM, Clem KJ, Rothrock SG. Ketamine safety profile in the developing world: survey of practitioners. Acad Emerg Med. 1996 Jun;3(6):598-604.
- Background: PubMed 2650898Reich DL, Silvay G. Ketamine: an update on the first twenty-five years of clinical experience. Can J Anaesth. 1989 Mar;36(2):186-97. doi: 10.1007/BF03011442.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest Nshom, MD study director
Cameroon Baptist Convention Health
Michael Runyon, MD study chair
Carolinas Medical Center
James R Young, MD principal investigator
Carolinas Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine, Normal Saline and Standard Pain Therapy in people with Sickle Cell Disease, run by Cameroon Baptist Convention Health at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cameroon, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James R Young, MD (704-578-5078, james.young@carolinashealthcare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02573714, which also lists 45 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.