Trial · NCT01784991
Study of Respiratory Depression When Using a Hydromorphone Pain Protocol
NCT01784991, Not applicable, Terminated, Albert Einstein Healthcare Network; results first posted 2020-03-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Respiratory Depression When Using a Hydromorphone Pain Protocol. Trials, record NCT01784991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01784991
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Respiratory Depression When Using a Hydromorphone Pain Protocol
- NCT number
- NCT01784991
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 116 participants, actual
- Lead sponsor
- Albert Einstein Healthcare Network
- Conditions
- Pain, Respiratory Depression
- Interventions
- Hydromorphone, Usual care group
- First posted
- 2013-02-06
- Last updated
- 2020-03-19
- Results first posted
- 2020-03-19
- Limitations and caveats
- 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Respiratory Depression | From administration of drug (time 0 minutes) to end of study (60 minute mark) | Incidence of respiratory depression (defined as a ETCO2 of 50 mmHg or greater, a 10% change from baseline, or loss of waveform for 15 seconds or greater) |
| Secondary | Successful Treatment of Patient Pain | 15 min and 60 min after baseline | Defined as: Declining additional pain medication at 15 minutes or requesting additional pain medication at 15 min, but declining at 60 minutes |
| Secondary | Change in VAS Score | 15 min and 60 min after baseline | A 13 mm change or greater on a VAS score |
| Secondary | Hypoxia | From administration of drug (time 0 minutes) to end of study (60 minute mark) | Defined as SpO2 of 93% or less for 15 seconds |
| Secondary | Hypotension | Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark) | Hypotension defined as systolic blood pressure less than 90 mmHg |
| Secondary | Allergic Reaction to Study Drug | From administration of drug (time 0 minutes) to end of study (60 minute mark) | |
| Secondary | Serious Adverse Events | From administration of drug (time 0 minutes) to end of study (60 minute mark) | Defined as prolonged hypoxia, need for positive pressure ventilation or intubation, hospital admission secondary to study drug. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Respiratory Depression | From administration of drug (time 0 minutes) to end of study (60 minute mark) | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | ||
| SECONDARY | Successful Treatment of Patient Pain | 15 min and 60 min after baseline | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | ||
| SECONDARY | Change in VAS Score | 15 min and 60 min after baseline | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | ||
| SECONDARY | Hypoxia | From administration of drug (time 0 minutes) to end of study (60 minute mark) | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | ||
| SECONDARY | Hypotension | Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark) | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | ||
| SECONDARY | Allergic Reaction to Study Drug | From administration of drug (time 0 minutes) to end of study (60 minute mark) | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | ||
| SECONDARY | Serious Adverse Events | From administration of drug (time 0 minutes) to end of study (60 minute mark) | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1mg + 1mg Hydromorphone | 0 | |
| Overall Study | STARTED | Usual Care Group | 0 | |
| Overall Study | COMPLETED | 1mg + 1mg Hydromorphone | 0 | |
| Overall Study | COMPLETED | Usual Care Group | 0 | |
| Overall Study | NOT COMPLETED | 1mg + 1mg Hydromorphone | 0 | |
| Overall Study | NOT COMPLETED | Usual Care Group | 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 | 1mg + 1mg Hydromorphone | 0 | 0 |
| Total, all-cause mortality | Usual Care Group | 0 | 0 |
| Total, other adverse events | 1mg + 1mg Hydromorphone | 0 | 0 |
| Total, other adverse events | Usual Care Group | 0 | 0 |
| Total, serious adverse events | 1mg + 1mg Hydromorphone | 0 | 0 |
| Total, serious adverse events | Usual Care Group | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01784991
GET https://conductscience.org/api/trials/v1/NCT01784991/registered