Trial · NCT04129086
Ketamine for Acute Pain Management After Trauma
NCT04129086, Phase 4, Completed, The University of Texas Health Science Center, Houston; results first posted 2023-04-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ketamine for Acute Pain Management After Trauma. Trials, record NCT04129086. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04129086
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ketamine for Acute Pain Management After Trauma
- NCT number
- NCT04129086
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 305 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Trauma Injury, Pain, Opioid Use
- Interventions
- Ketamine plus usual care, Usual Care
- First posted
- 2019-10-16
- Last updated
- 2023-04-21
- Results first posted
- 2023-04-21
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day | In-hospital days (up to 6 weeks post hospital admission) | |
| Secondary | Pain as Assessed by Score on the Numeric Rating Scale (NRS) | Hospital discharge (up to 6 weeks post hospital admission) | The NRS ranges from 0 (no pain) to 10 (worst pain), with a higher score indicating a worse outcome. This scale is used in verbal participants. |
| Secondary | Number of Patients That Showed Signs of Delirium During In-hospital Stay | Hospital discharge (up to 6 weeks post hospital admission) | Incidence of delirium during in-hospital stay |
| Secondary | Number of Patients That Required Unplanned Intubation During In-hospital Stay | Hospital discharge (up to 6 weeks post hospital admission) | incidence of need for unplanned intubation during in-hospital stay |
| Secondary | Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay | Hospital discharge (up to 6 weeks post hospital admission) | Incidence of need for unplanned admission to an ICU |
| Secondary | Initiation of Ketamine Drip | Hospital discharge (up to 6 weeks post hospital admission) | Time from admission to time Ketamine drip started |
| Secondary | Duration of Ketamine Drip | Hospital discharge (up to 6 weeks post hospital admission) | Length of time Ketamine drip was infused |
| Secondary | Number of Patients Requesting to Discontinue Ketamine | Hospital discharge (up to 6 weeks post hospital admission) | Number of patients requesting to stop Ketamine for any complaint |
| Secondary | Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch | Hospital discharge (up to 6 weeks post hospital admission) | Incidence of use of additional pain control adjuncts such as regional anesthesia and lidocaine patch during hospitalization |
| Secondary | Ventilator Free Days | Hospital discharge (up to 6 weeks post hospital admission) | Number of inpatient hospital days patients did not require mechanical ventilation |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day | In-hospital days (up to 6 weeks post hospital admission) | MME per day | MEAN | |
| SECONDARY | Pain as Assessed by Score on the Numeric Rating Scale (NRS) | Hospital discharge (up to 6 weeks post hospital admission) | Data were not collected for this outcome measure | ||
| SECONDARY | Number of Patients That Showed Signs of Delirium During In-hospital Stay | Hospital discharge (up to 6 weeks post hospital admission) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients That Required Unplanned Intubation During In-hospital Stay | Hospital discharge (up to 6 weeks post hospital admission) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay | Hospital discharge (up to 6 weeks post hospital admission) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Initiation of Ketamine Drip | Hospital discharge (up to 6 weeks post hospital admission) | Data were not collected for this outcome measure | ||
| SECONDARY | Duration of Ketamine Drip | Hospital discharge (up to 6 weeks post hospital admission) | hours | MEDIAN | |
| SECONDARY | Number of Patients Requesting to Discontinue Ketamine | Hospital discharge (up to 6 weeks post hospital admission) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch | Hospital discharge (up to 6 weeks post hospital admission) | Lidocaine drip was not used in clinic. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Ventilator Free Days | Hospital discharge (up to 6 weeks post hospital admission) | days | MEDIAN |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group180
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day | Ketamine Plus Usual Care | 32 | 95% Confidence Interval 29 to 36 | MME per day | |
| Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day | Usual Care | 39 | 95% Confidence Interval 35 to 44 | MME per day | |
| Number of Patients That Showed Signs of Delirium During In-hospital Stay | Ketamine Plus Usual Care | 16 | Participants | ||
| Number of Patients That Showed Signs of Delirium During In-hospital Stay | Usual Care | 9 | Participants | ||
| Number of Patients That Required Unplanned Intubation During In-hospital Stay | Ketamine Plus Usual Care | 2 | Participants | ||
| Number of Patients That Required Unplanned Intubation During In-hospital Stay | Usual Care | 3 | Participants | ||
| Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay | Ketamine Plus Usual Care | 7 | Participants | ||
| Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay | Usual Care | 7 | Participants | ||
| Duration of Ketamine Drip | Ketamine Plus Usual Care | 60 | Inter-Quartile Range 32 to 86 | hours | |
| Duration of Ketamine Drip | Usual Care | 76 | Inter-Quartile Range 31 to 94 | hours |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ketamine Plus Usual Care | 144 | |
| Overall Study | STARTED | Usual Care | 156 | |
| Overall Study | COMPLETED | Ketamine Plus Usual Care | 144 | |
| Overall Study | COMPLETED | Usual Care | 156 | |
| Overall Study | NOT COMPLETED | Ketamine Plus Usual Care | 0 | |
| Overall Study | NOT COMPLETED | Usual Care | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ketamine Plus Usual Care | 1 | 144 |
| Total, all-cause mortality | Usual Care | 6 | 156 |
| Total, other adverse events | Ketamine Plus Usual Care | 0 | 144 |
| Total, other adverse events | Usual Care | 0 | 156 |
| Total, serious adverse events | Ketamine Plus Usual Care | 0 | 144 |
| Total, serious adverse events | Usual Care | 0 | 156 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ketamine Plus Usual Care vs Usual Care: Number of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission | Trial comparisons |
| Ketamine Plus Usual Care vs Usual Care: Number of Patients Who Continue to Use Opioids at 6 Months Post Admission | Trial comparisons |
| Ketamine Plus Usual Care vs Usual Care: Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay | Trial comparisons |
| Ketamine Plus Usual Care vs Usual Care: Number of Patients Requesting to Discontinue Ketamine | Trial comparisons |
| Ketamine Plus Usual Care vs Usual Care: Number of Patients That Showed Signs of Delirium During In-hospital Stay | Trial comparisons |
| Ketamine Plus Usual Care vs Usual Care: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) | Trial comparisons |
| Ketamine Plus Usual Care vs Usual Care: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) | Trial comparisons |
| Ketamine Plus Usual Care vs Usual Care: Number of Patients That Required Unplanned Intubation During In-hospital Stay | Trial comparisons |
| Ketamine Plus Usual Care vs Usual Care: deaths from any cause | Trial comparisons |
| Ketamine Plus Usual Care vs Usual Care: 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/NCT04129086
GET https://conductscience.org/api/trials/v1/NCT04129086/registered?page=2