Ketamine for Acute Painful Crisis in Sickle Cell Disease Patients

NCT03431285 | Completed Results DMC

• 1 other identifier: IR3- 2017-01- 192
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Crisis

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Mean difference in the numerical pain rating scale score over 3 hours. Pain was measured on a scale from 0 (no pain) to 10 (the worst pain)

  NPRS will be recorded every 30 minutes for a maximum of 180 minutes.

Secondary Outcomes (4)

• Length of Stay in ED

  for 5 hours following admission to ED

• Cumulative Use of Opioid

  for 3 hours following admission to the ED

• The Rate of Hospital Admission

  within 3 hours following study enrollment

• Drug-related Adverse Effects

  3 hours following drug administration

Study Arms (2)

Morphine Group

ACTIVE COMPARATOR

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; Other: standard IV hydration

Ketamine Group

ACTIVE COMPARATOR

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; Other: standard IV hydration

Interventions

Morphine Group DRUG

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.

Also known as: Control Group

Morphine Group

Ketamine Group DRUG

Patients will receive low dose ketamine 0.3 mg/kg in 100ml N.S. infused over 30 min in addition to standard IV hydration

Also known as: Intervention Group

Ketamine Group

standard IV hydration OTHER

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)

Ketamine Group; Morphine Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

Imam Abdulrahman Bin Faisal University

Dammam, Eastern Province, 31952, Saudi Arabia

Location

Related Publications (1)

• Alshahrani MS, Asonto LP, El Tahan MM, Al Sulaibikh AH, Al Faraj SZ, Al Mulhim AA, Al Abbad MF, Al Nahhash SA, Aldarweesh MN, Mahmoud AM, Almaghraby N, Al Jumaan MA, Al Junaid TO, Al Hawaj FM, AlKenany S, ElSayed OF, Abdelwahab HM, Moussa MM, Alossaimi BK, Alotaibi SK, AlMutairi TM, AlSulaiman DA, Al Shahrani SD, Alfaraj D, Alhazzani W. Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease. Trials. 2019 May 27;20(1):286. doi: 10.1186/s13063-019-3394-4.

  PMID: 31133061 DERIVED

MeSH Terms

Conditions

Vaso-Occlusive Crises

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

Limitations included this being a single centre trial, thereby restricting the generalizability of the findings. Also, 180 minutes might be a short timeframe to assess impact of a study drug. Moreover, we calculated the use of a single low dose of ketamine that might be inadequate to provide our hypothesized superiority in the ketamine treated arm. Therefore, future studies

Results Point of Contact

• Title: Dr. Muhammed Alshahrani
• Organization: King Fahd University Hospital- Imam Abdulrahman Bin Faisal University

msshahrani@iau.edu.sa

+966138966666

Study Officials

• Mohammed SS Alshahrani, MD

  King Fahad Hospital of the University -Imam Abdulrahman Bin Faisal University - (Dammam University)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Triple-blind study. The study solution will be prepared in identical 100-ml Normal Saline bags by the research nurse
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor - Emergency medicine

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 13, 2018
• Study Start: January 1, 2018
• Primary Completion: January 10, 2019
• Study Completion: February 1, 2019
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: for 5 years after completing the study
• Access Criteria: Through direct contact with the Principal Investigator

Locations

SA (1)