Trial · NCT01949662
Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer
NCT01949662, Phase 2, Active not recruiting, M.D. Anderson Cancer Center; results first posted 2020-10-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer. Trials, record NCT01949662. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01949662
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer
- NCT number
- NCT01949662
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 93 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Advanced Cancers
- Interventions
- Lorazepam, Placebo, Haloperidol decanoate, Questionnaires
- First posted
- 2013-09-24
- Last updated
- 2026-07-17
- Results first posted
- 2020-10-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points | Baseline to 8 hours | The primary outcome was change in Richmond Agitation-Sedation Scale score from baseline to 8 hours after treatment administration. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient. |
| Primary | Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points | 8 hours | Absolute score of Richmond Agitation-Sedation Scale at 8 hr, points. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient. |
| Secondary | Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min | Baseline to 30 minutes | Change in Richmond Agitation-Sedation Scale score from baseline to 30 min. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient. |
| Secondary | Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr | Baseline to 8 hours | Number of participants with Richmond Agitation-Sedation Scale score \>=1 within 8 hr. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points | Baseline to 8 hours | Intent to treat 58 participants, a total of 29 for each arm; 3 participants were lost to follow up from each arm. | score on a scale | MEAN |
| PRIMARY | Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points | 8 hours | Intent to treat 58 participants, a total of 29 for each arm; 3 participants were lost to follow up from each arm. | score on a scale | MEAN |
| SECONDARY | Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min | Baseline to 30 minutes | Intent to treat 58 participants, a total of 29 for each arm | score on a scale | MEAN |
| SECONDARY | Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr | Baseline to 8 hours | Intent to treat 58 participants, a total of 29 from each arm | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points | Intervention Group (Lorazepam & Haloperidol) | -4.1 | 95% Confidence Interval -4.8 to -3.4 | score on a scale | |
| Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points | Control Group (Placebo & Haloperidol) | -2.3 | 95% Confidence Interval -2.9 to -1.6 | score on a scale | |
| Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points | Intervention Group (Lorazepam & Haloperidol) | -2.5 | 95% Confidence Interval -3.2 to -1.9 | score on a scale | |
| Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points | Control Group (Placebo & Haloperidol) | -0.7 | 95% Confidence Interval -1.3 to -0.1 | score on a scale | |
| Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min | Intervention Group (Lorazepam & Haloperidol) | -3.6 | 95% Confidence Interval -4.3 to -2.9 | score on a scale | |
| Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min | Control Group (Placebo & Haloperidol) | -1.6 | 95% Confidence Interval -2.2 to -1.0 | score on a scale | |
| Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr | Intervention Group (Lorazepam & Haloperidol) | 8 | Participants | ||
| Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr | Control Group (Placebo & Haloperidol) | 22 | 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 | Intervention Group (Lorazepam & Haloperidol) | 47 | |
| Overall Study | STARTED | Control Group (Placebo & Haloperidol) | 43 | |
| Overall Study | COMPLETED | Intervention Group (Lorazepam & Haloperidol) | 29 | |
| Overall Study | COMPLETED | Control Group (Placebo & Haloperidol) | 29 | |
| Overall Study | NOT COMPLETED | Intervention Group (Lorazepam & Haloperidol) | 18 | |
| Overall Study | NOT COMPLETED | Control Group (Placebo & Haloperidol) | 14 |
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 | Hypokinesia | Musculoskeletal and connective tissue disorders | Intervention Group (Lorazepam & Haloperidol) | 3 | 29 | |
| other | Hypokinesia | Musculoskeletal and connective tissue disorders | Control Group (Placebo & Haloperidol) | 4 | 29 | |
| other | Hyperkinesia | Musculoskeletal and connective tissue disorders | Intervention Group (Lorazepam & Haloperidol) | 1 | 29 | |
| other | Hyperkinesia | Musculoskeletal and connective tissue disorders | Control Group (Placebo & Haloperidol) | 2 | 29 | |
| other | Akathisia | Musculoskeletal and connective tissue disorders | Intervention Group (Lorazepam & Haloperidol) | 3 | 29 | |
| other | Akathisia | Musculoskeletal and connective tissue disorders | Control Group (Placebo & Haloperidol) | 1 | 29 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention Group (Lorazepam & Haloperidol) | 10 | 47 |
| Total, all-cause mortality | Control Group (Placebo & Haloperidol) | 10 | 43 |
| Total, other adverse events | Intervention Group (Lorazepam & Haloperidol) | 3 | 29 |
| Total, other adverse events | Control Group (Placebo & Haloperidol) | 4 | 29 |
| Total, serious adverse events | Intervention Group (Lorazepam & Haloperidol) | 0 | 29 |
| Total, serious adverse events | Control Group (Placebo & Haloperidol) | 0 | 29 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28975307 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21CA186000 | Adjuvant Lorazepam for Agitated Delirium in the Palliative Care Unit | HUI, DAVID | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 2015 to 2016 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention Group (Lorazepam & Haloperidol) vs Control Group (Placebo & Haloperidol): Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr | Trial comparisons |
| Intervention Group (Lorazepam & Haloperidol) vs Control Group (Placebo & Haloperidol): deaths from any cause | Trial comparisons |
| Intervention Group (Lorazepam & Haloperidol) vs Control Group (Placebo & Haloperidol): 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/NCT01949662
GET https://conductscience.org/api/trials/v1/NCT01949662/registered