Trial · NCT03431285
Ketamine for Acute Painful Crisis in Sickle Cell Disease Patients
NCT03431285, Not applicable, Completed, Imam Abdulrahman Bin Faisal University; results first posted 2025-05-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ketamine for Acute Painful Crisis in Sickle Cell Disease Patients. Trials, record NCT03431285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03431285
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ketamine for Acute Painful Crisis in Sickle Cell Disease Patients
- NCT number
- NCT03431285
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 278 participants, actual
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Conditions
- Sickle Cell Crisis
- Interventions
- Morphine Group, Ketamine Group, standard IV hydration
- First posted
- 2018-02-13
- Last updated
- 2025-05-28
- Results first posted
- 2025-05-28
- 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
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Scores | 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) |
| Secondary | Length of Stay in ED | for 5 hours following admission to ED | Described as time elapsed from the start of study medication to the readiness for hospital discharge. |
| Secondary | Cumulative Use of Opioid | for 3 hours following admission to the ED | The cumulative use of opioid will be recorded during the ED stay |
| Secondary | The Rate of Hospital Admission | within 3 hours following study enrollment | Number of admitted patients to the hospital after enrollment to study |
| Secondary | Drug-related Adverse Effects | 3 hours following drug administration | flushing, hypotension, altered mental status, itching, paresthesia, respiratory depression, dizziness, nausea, vomiting |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Scores | NPRS will be recorded every 30 minutes for a maximum of 180 minutes. | intention to treat (ITT) | score on a scale | MEAN |
| SECONDARY | Length of Stay in ED | for 5 hours following admission to ED | intention to treat (ITT) | hours | MEAN |
| SECONDARY | Cumulative Use of Opioid | for 3 hours following admission to the ED | intention to treat (ITT) | mg/kg | MEAN |
| SECONDARY | The Rate of Hospital Admission | within 3 hours following study enrollment | intention to treat analysis (ITT) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Drug-related Adverse Effects | 3 hours following drug administration | intention to treat (ITT) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Scores | Morphine Group | 5.6 | Standard Deviation 1.90 | score on a scale | |
| Pain Scores | Ketamine Group | 5.7 | Standard Deviation 2.13 | score on a scale | |
| Length of Stay in ED | Morphine Group | 4.8 | Standard Deviation 2.47 | hours | |
| Length of Stay in ED | Ketamine Group | 4.7 | Standard Deviation 1.98 | hours | |
| Cumulative Use of Opioid | Morphine Group | 0.13 | Standard Deviation 0.11 | mg/kg | |
| Cumulative Use of Opioid | Ketamine Group | 0.07 | Standard Deviation 0.07 | mg/kg | |
| The Rate of Hospital Admission | Morphine Group | 34 | Participants | ||
| The Rate of Hospital Admission | Ketamine Group | 26 | Participants | ||
| Drug-related Adverse Effects | Morphine Group | 3 | Participants | ||
| Drug-related Adverse Effects | Ketamine Group | 8 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Morphine Group | 140 | |
| Overall Study | STARTED | Ketamine Group | 138 | |
| Overall Study | COMPLETED | Morphine Group | 140 | |
| Overall Study | COMPLETED | Ketamine Group | 138 | |
| Overall Study | NOT COMPLETED | Morphine Group | 0 | |
| Overall Study | NOT COMPLETED | Ketamine Group | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nausea | Gastrointestinal disorders | Morphine Group | 0 | 140 | 0 |
| other | nausea | Gastrointestinal disorders | Ketamine Group | 4 | 138 | 4 |
| other | dizziness | Ear and labyrinth disorders | Morphine Group | 3 | 140 | 3 |
| other | dizziness | Ear and labyrinth disorders | Ketamine Group | 3 | 138 | 3 |
| other | vomiting | Gastrointestinal disorders | Morphine Group | 0 | 140 | 0 |
| other | vomiting | Gastrointestinal disorders | Ketamine Group | 1 | 138 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Morphine Group | 0 | 140 |
| Total, all-cause mortality | Ketamine Group | 0 | 138 |
| Total, other adverse events | Morphine Group | 3 | 140 |
| Total, other adverse events | Ketamine Group | 8 | 138 |
| Total, serious adverse events | Morphine Group | 0 | 140 |
| Total, serious adverse events | Ketamine Group | 0 | 138 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31133061 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Morphine Group vs Ketamine Group: The Rate of Hospital Admission | Trial comparisons |
| Morphine Group vs Ketamine Group: Drug-related Adverse Effects | Trial comparisons |
| Morphine Group vs Ketamine Group: deaths from any cause | Trial comparisons |
| Morphine Group vs Ketamine Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03431285
GET https://conductscience.org/api/trials/v1/NCT03431285/registered