ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketamine for Acute Painful Crisis in Sickle Cell Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03431285
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Mohammed Saeed Saad Alshahrani, Dammam University

Brief Summary:
Investigators hypothesize that administration of ketamine for pain relief in sickle cell patients with vaso-occlusive crisis early on will lead to a more rapid improvement in pain score and less narcotic requirement.

Condition or disease Intervention/treatment Phase
Sickle Cell Crisis Drug: Morphine Group Drug: Ketamine Group Other: standard IV hydration Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Triple-blind study. The study solution will be prepared in identical 100-ml Normal Saline bags by the research nurse
Primary Purpose: Treatment
Official Title: Ketamine for Acute Painful Crisis in Sickle Cell Disease Patients: Prospective Randomized Control Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : February 27, 2019


Arm Intervention/treatment
Active Comparator: Morphine Group
Patients will receive standard dose of morphine (0.1 mg/kg) in 100 ml normal saline (NS) infused over 30 minutes in addition to standard IV hydration.
Drug: Morphine Group
Patients will receive standard dose of morphine (0.1 mg/kg) in 100 ml normal saline infused over 30 min in addition to standard IV hydration.
Other Name: Control Group

Other: standard IV hydration
IV hydration as per our institutional protocol (Lactated Ringer's or NaCl 0.9% solution will be infused at a rate of 2-3 ml/kg/h)

Active Comparator: Ketamine Group
Patients will receive low dose ketamine 0.3 mg/kg in 100ml normal saline (NS) infused over 30 minutes in addition to standard IV hydration
Drug: Ketamine Group
Patients will receive low dose ketamine 0.3 mg/kg in 100ml N.S. infused over 30 min in addition to standard IV hydration
Other Name: Intervention Group

Other: standard IV hydration
IV hydration as per our institutional protocol (Lactated Ringer's or NaCl 0.9% solution will be infused at a rate of 2-3 ml/kg/h)




Primary Outcome Measures :
  1. Pain scores [ Time Frame: for 6 hours following admission to the ED ]
    Improvement of pain scores using Numerical Pain Rating Score (NPRS) (0: no pain, 10: worst imaginable pain)


Secondary Outcome Measures :
  1. Length of stay in ED [ Time Frame: for 6 hours following admission to ED ]
    Described as time elapsed from the start of study medication to the readiness for hospital discharge

  2. Cumulative use of opioid [ Time Frame: for 6 hours following admission to the ED ]
    The cumulative use of opioid will be recorded during the ED stay

  3. The rate of hospital admission [ Time Frame: for 6 hours following admission to the ED ]
    Number of patients admitted to the hospital after admission to the ED during the same admission

  4. Drug-related adverse effects [ Time Frame: for 24 hours following admission to the ED ]
    flushing, hypotension, altered mental status, itching, paraesthesia, respiratory depression, dizziness, nausea, vomiting



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Known diagnosis of SCD based on sickle cell tests and hemoglobin electrophoresis.
  • Age 18 to 60 years
  • Acute onset of painful crises, defined as having an onset within 7 days

Exclusion Criteria:

  • Pregnancy
  • Breast-feeding
  • Altered mental status
  • Body mass index greater than 40 kg/m2
  • Patients with significant neurological disease
  • Seizures
  • Acute head injury
  • Acute eye injury
  • Patients with high intra-cranial tension
  • Patients with known psychiatric disorders
  • Patients with significant cardiac diseases
  • Arrhythmias
  • Patients with significant pulmonary diseases rather than acute chest syndrome
  • Patients with significant renal disease (BUN/creatinine ratio < 25)
  • Patients with significant hepatic disease (Child Pugh class B or C)
  • Patients with significant endocrine disease
  • Known allergy to phencyclidine derivatives
  • Known allergy to ketamine
  • Known allergy to morphine
  • Sepsis
  • Septic shock
  • Patients required circulatory support
  • Patients required ventilatory supports
  • Alcohol abuse
  • Drug abuse
  • Patients with chronic pain status unrelated to SCD
  • Patients receiving anti-convulsant medications
  • Patients receiving anti-psychiatric medications.
  • Patients with communication barriers.

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): NCT03431285


Contacts
Contact: Mohammed SS Alshahrani, MD +966 55 696 6663 msshahrani@iau.edu.sa
Contact: Laila P Asonto +966 55 458 6033 lasonto@iau.edu.sa

Locations
Saudi Arabia
Imam Abdulrahman Bin Faisal University Recruiting
Dammam, Eastern, Saudi Arabia, 31952
Contact: Mohammed SS Alshahrani, MD    +966 55 696 6663    msshahrani@iau.edu.sa   
Contact: Laila P Asonto, MD    +966 55 458 6033    lasonto@iau.edu.sa   
Sponsors and Collaborators
Dammam University
Investigators
Study Chair: Mohammed SS Alshahrani, MD Emergency and Critical Care Medicine Consultant Director, Critical Care Medicine Department Medical Director, King Fahad Hospital of the University Associate Professor - College of Medicine Imam Abdulrahman Bin Faisal University - (Dammam University)

Responsible Party: Mohammed Saeed Saad Alshahrani, Associate professor - Emergency medicine, Dammam University
ClinicalTrials.gov Identifier: NCT03431285     History of Changes
Other Study ID Numbers: IR3‐ 2017‐01‐ 192
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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