NCT03431285

Ketamine for Acute Painful Crisis in Sickle Cell Disease Patients

Completed NA Results posted Last updated 28 May 2025

What this trial tests

NA trial testing Morphine Group in Sickle Cell Crisis in 278 participants. Completed in 1 February 2019.

Timeline

1 January 2018

Primary endpoint
10 January 2019

1 February 2019

Quick facts

Lead sponsor	Imam Abdulrahman Bin Faisal University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	278
Start date	1 January 2018
Primary completion	10 January 2019
Estimated completion	1 February 2019
Sites	1 location across Saudi Arabia

Drugs / interventions tested

• Morphine Group
• Ketamine Group
• standard IV hydration

Conditions studied

• Sickle Cell Crisis — all drugs for Sickle Cell Crisis →

Sponsor

Imam Abdulrahman Bin Faisal University

Who can join

Adults 18 to 60, any sex, with Sickle Cell Crisis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Scores Primary · NPRS will be recorded every 30 minutes for a maximum of 180 minutes.

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)

Group	Value	95% CI
Morphine Group	5.6	± 1.90
Ketamine Group	5.7	± 2.13

Length of Stay in ED Secondary · for 5 hours following admission to ED

Described as time elapsed from the start of study medication to the readiness for hospital discharge.

Group	Value	95% CI
Morphine Group	4.8	± 2.47
Ketamine Group	4.7	± 1.98

Cumulative Use of Opioid Secondary · for 3 hours following admission to the ED

The cumulative use of opioid will be recorded during the ED stay

Group	Value	95% CI
Morphine Group	0.13	± 0.11
Ketamine Group	0.07	± 0.07

The Rate of Hospital Admission Secondary · within 3 hours following study enrollment

Number of admitted patients to the hospital after enrollment to study

Group	Value	95% CI
Morphine Group	34
Ketamine Group	26

Drug-related Adverse Effects Secondary · 3 hours following drug administration

flushing, hypotension, altered mental status, itching, paresthesia, respiratory depression, dizziness, nausea, vomiting

Group	Value	95% CI
Morphine Group	3
Ketamine Group	8

Adverse events — posted to ClinicalTrials.gov

Time frame: 180 minutes. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Morphine Group

Serious: 0/140 (0%)

Deaths: 0/140

Ketamine Group

Serious: 0/138 (0%)

Deaths: 0/138

Other adverse events (3 terms — click to expand)

Reaction	System	Morphine Group	Ketamine Group
nausea	Gastrointestinal disorders	—	—
dizziness	Ear and labyrinth disorders	—	—
vomiting	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT03431285 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ketamine administration for acute painful sickle cell crisis: A randomized controlled trial.
   Alshahrani MS, AlSulaibikh AH, ElTahan MR, AlFaraj SZ, et al · · 2022 · cited 34× · PMID 34449939 · DOI 10.1111/acem.14382
2. New insights into the pathophysiology and development of novel therapies for sickle cell disease.
   Moerdler S, Manwani D. · · 2018 · cited 24× · PMID 30504350 · DOI 10.1182/asheducation-2018.1.493
3. Ketamine for Sickle Cell Vaso-Occlusive Crises: A Systematic Review.
   Alshahrani MS, Alghamdi MA. · · 2021 · cited 15× · PMID 33519337 · DOI 10.4103/sjmms.sjmms_218_20
4. Pharmacological interventions for painful sickle cell vaso-occlusive crises in adults.
   Cooper TE, Hambleton IR, Ballas SK, Johnston BA, et al · · 2019 · cited 15× · PMID 31742673 · DOI 10.1002/14651858.cd012187.pub2
5. Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease.
   Alshahrani MS, Asonto LP, El Tahan MM, Al Sulaibikh AH, et al · · 2019 · cited 4× · PMID 31133061 · DOI 10.1186/s13063-019-3394-4