Trial Outcomes & Findings for Ketamine for Acute Painful Crisis in Sickle Cell Disease Patients (NCT NCT03431285)
NCT ID: NCT03431285
Last Updated: 2025-05-28
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
278 participants
Primary outcome timeframe
NPRS will be recorded every 30 minutes for a maximum of 180 minutes.
Results posted on
2025-05-28
Participant Flow
Completed
Participant milestones
| Measure |
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.
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.
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)
|
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
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
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)
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
138
|
|
Overall Study
COMPLETED
|
140
|
138
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine for Acute Painful Crisis in Sickle Cell Disease Patients
Baseline characteristics by cohort
| Measure |
Morphine Group
n=140 Participants
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.
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.
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)
|
Ketamine Group
n=138 Participants
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
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
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)
|
Total
n=278 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
29.4 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
140 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Saudi Arabia
|
140 participants
n=5 Participants
|
138 participants
n=7 Participants
|
278 participants
n=5 Participants
|
|
Numerical Pain Rating Scale
|
8.7 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
8.6 units on a scale
STANDARD_DEVIATION 1.3 • n=7 Participants
|
8.6 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: NPRS will be recorded every 30 minutes for a maximum of 180 minutes.Population: intention to treat (ITT)
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)
Outcome measures
| Measure |
Morphine Group
n=140 Participants
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.
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.
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)
|
Ketamine Group
n=138 Participants
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
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
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)
|
|---|---|---|
|
Pain Scores
|
5.6 score on a scale
Standard Deviation 1.90
|
5.7 score on a scale
Standard Deviation 2.13
|
SECONDARY outcome
Timeframe: for 5 hours following admission to EDPopulation: intention to treat (ITT)
Described as time elapsed from the start of study medication to the readiness for hospital discharge.
Outcome measures
| Measure |
Morphine Group
n=140 Participants
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.
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.
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)
|
Ketamine Group
n=138 Participants
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
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
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)
|
|---|---|---|
|
Length of Stay in ED
|
4.8 hours
Standard Deviation 2.47
|
4.7 hours
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: for 3 hours following admission to the EDPopulation: intention to treat (ITT)
The cumulative use of opioid will be recorded during the ED stay
Outcome measures
| Measure |
Morphine Group
n=140 Participants
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.
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.
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)
|
Ketamine Group
n=138 Participants
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
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
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)
|
|---|---|---|
|
Cumulative Use of Opioid
|
0.13 mg/kg
Standard Deviation 0.11
|
0.07 mg/kg
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: within 3 hours following study enrollmentPopulation: intention to treat analysis (ITT)
Number of admitted patients to the hospital after enrollment to study
Outcome measures
| Measure |
Morphine Group
n=140 Participants
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.
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.
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)
|
Ketamine Group
n=138 Participants
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
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
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)
|
|---|---|---|
|
The Rate of Hospital Admission
|
34 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 3 hours following drug administrationPopulation: intention to treat (ITT)
flushing, hypotension, altered mental status, itching, paresthesia, respiratory depression, dizziness, nausea, vomiting
Outcome measures
| Measure |
Morphine Group
n=140 Participants
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.
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.
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)
|
Ketamine Group
n=138 Participants
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
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
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)
|
|---|---|---|
|
Drug-related Adverse Effects
|
3 Participants
|
8 Participants
|
Adverse Events
Morphine Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ketamine Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Morphine Group
n=140 participants at risk
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.
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.
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)
|
Ketamine Group
n=138 participants at risk
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
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
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)
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
0.00%
0/140 • 180 minutes
|
2.9%
4/138 • Number of events 4 • 180 minutes
|
|
Ear and labyrinth disorders
dizziness
|
2.1%
3/140 • Number of events 3 • 180 minutes
|
2.2%
3/138 • Number of events 3 • 180 minutes
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/140 • 180 minutes
|
0.72%
1/138 • Number of events 1 • 180 minutes
|
Additional Information
Dr. Muhammed Alshahrani
King Fahd University Hospital- Imam Abdulrahman Bin Faisal University
Phone: +966138966666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place