Trial · NCT02156154
Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications
NCT02156154, Phase 3, Completed, The Cleveland Clinic; results first posted 2021-04-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications. Trials, record NCT02156154. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02156154
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications
- NCT number
- NCT02156154
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 580 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Postoperative Pain
- Interventions
- Intravenous Acetaminophen
- First posted
- 2014-06-05
- Last updated
- 2021-04-20
- Results first posted
- 2021-04-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Hypoxemia | the initial 48 hours of postoperative monitoring or for the duration of hospitalization, if shorter. | Hypoxemia is measured as minutes with hypoxemia (Spo2 \<90%) per hour of successful Spo2 monitoring. Patients will have nearly continuous pulseoximeter monitoring and recording. Data from the monitor will be downloaded daily for 48 hours postoperatively. |
| Secondary | Time-weighted Pain Score During Initial 48 Postoperative Hours | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) | Pain scores were calculated on a visual analog scale of 0 to 10, with 0 being no pain and 10 being the most pain imaginable; time weighted mean was calculated as the area under the curve of the pain score measurements divided by total measurement time. Pain was recorded at roughly 15-minute intervals in the postanesthesia care unit and at 4-hour intervals on surgical wards |
| Secondary | Time Weighted Pain Score in Post Anesthesia Care Unit | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) | Pain scores were calculated on a visual analog scale of 0 to 10, with 0 being no pain and 10 being the most pain imaginable; time-weighted mean was calculated as the area under the curve of the pain score measurements divided by total measurement time. |
| Secondary | Fatigue Score on Morning of Postoperative Day 1 | Postoperative day 1 | Fatigue scores were calculated on a scale of 1 to 10, with 1 being no fatigue and 10 being the worst fatigue imaginable. |
| Secondary | Lowest RASS Score During Initial 48 Postoperative Hours | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) | Sedation was estimated by the RASS score and recorded at 2-hour intervals by ward nurses per clinical routine during the initial 48 postoperative hours. The Richmond Agitation-Sedation Scale (RASS) is scored from -5 to +4, with -5 being unarousable, 0 being alert and calm, and +4 being combative. |
| Secondary | Time Spent in Sitting or Upright Position | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) | Treatment effect data are reported as ratios of geometric means |
| Secondary | Opioid Consumption - Intravenous Morphine Equivalents | Initial 48 postoperative hours | Total opioid consumption over the initial 48 postoperative hours was extracted from patients' medical records and converted to intravenous morphine equivalents |
| Secondary | Incidence of Postoperative Nausea and Vomiting | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) | Patients were asked about postoperative nausea and vomiting in the postanesthesia care unit, at 4-hour intervals while awake through the remaining initial day of surgery, and on the first and second postoperative mornings. |
| Secondary | Incidence of Low Respiratory Function Event | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) | A low respiratory function event was defined as an episode of less than 40% of predicted minute ventilation for 2 minutes. |
| Secondary | Total Anesthetic Dose From Induction to Extubation | Induction to extubation (3 hours on average) | Total anesthetic dose is measured in minimal alveolar concentration hours. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration of Hypoxemia | the initial 48 hours of postoperative monitoring or for the duration of hospitalization, if shorter. | Patients were analyzed according to their randomized group, excluding patients who did not receive study intervention. 28 patients (5%) did not have any data recorded due to unexpected technical issues. | min/h | MEDIAN |
| SECONDARY | Time-weighted Pain Score During Initial 48 Postoperative Hours | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) | Data on the outcome could not be collected for 7 patients in the IV acetaminophen group and 5 patients in the IV sodium chloride group. | score on a scale | MEAN |
| SECONDARY | Time Weighted Pain Score in Post Anesthesia Care Unit | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) | Data on the outcome could not be collected for 2 patients in the IV acetaminophen group and 6 patients in the IV sodium chloride group. | score on a scale | MEAN |
| SECONDARY | Fatigue Score on Morning of Postoperative Day 1 | Postoperative day 1 | Data on the outcome could not be collected for 12 patients in the IV acetaminophen group and 15 patients in the IV sodium chloride group. | score on a scale | MEAN |
| SECONDARY | Lowest RASS Score During Initial 48 Postoperative Hours | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) | Data on the outcome could not be collected for 91 patients in the IV acetaminophen group and 86 patients in the IV sodium chloride group. | score on a scale | MEAN |
| SECONDARY | Time Spent in Sitting or Upright Position | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) | Data on the outcome could not be collected for 31 patients in the IV acetaminophen group and 37 patients in the IV sodium chloride group. | hours | MEDIAN |
| SECONDARY | Opioid Consumption - Intravenous Morphine Equivalents | Initial 48 postoperative hours | Data on the outcome could not be collected for 3 patients in the IV acetaminophen group and 7 patients in the IV sodium chloride group. | mg | MEDIAN |
| SECONDARY | Incidence of Postoperative Nausea and Vomiting | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) | Data on the outcome could not be collected for 3 patients in the IV acetaminophen group and 7 patients in the IV sodium chloride group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Low Respiratory Function Event | Initial 48 postoperative hours or duration of hospitalization (whichever comes first) | Data on the outcome could not be collected for 95 patients in the IV acetaminophen group and 124 patients in the IV sodium chloride group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Total Anesthetic Dose From Induction to Extubation | Induction to extubation (3 hours on average) | Data on the outcome could not be collected for 1 patient in the IV acetaminophen group. | minimal alveolar concentration hours | MEDIAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Hypoxemia | Intravenous Acetaminophen | 0.7 | Inter-Quartile Range 0.1 to 5.1 | min/h | |
| Duration of Hypoxemia | Intravenous 0.9% Sodium Chloride | 1.1 | Inter-Quartile Range 0.1 to 6.6 | min/h | |
| Time-weighted Pain Score During Initial 48 Postoperative Hours | Intravenous Acetaminophen | 4.2 | Standard Deviation 1.8 | score on a scale | |
| Time-weighted Pain Score During Initial 48 Postoperative Hours | Intravenous 0.9% Sodium Chloride | 4.4 | Standard Deviation 1.8 | score on a scale | |
| Time Weighted Pain Score in Post Anesthesia Care Unit | Intravenous Acetaminophen | 4.3 | Standard Deviation 1.7 | score on a scale | |
| Time Weighted Pain Score in Post Anesthesia Care Unit | Intravenous 0.9% Sodium Chloride | 4.4 | Standard Deviation 1.8 | score on a scale | |
| Fatigue Score on Morning of Postoperative Day 1 | Intravenous Acetaminophen | 5 | Standard Deviation 2.6 | score on a scale | |
| Fatigue Score on Morning of Postoperative Day 1 | Intravenous 0.9% Sodium Chloride | 4.9 | Standard Deviation 2.7 | score on a scale | |
| Lowest RASS Score During Initial 48 Postoperative Hours | Intravenous Acetaminophen | -0.96 | Standard Deviation 0.75 | score on a scale | |
| Lowest RASS Score During Initial 48 Postoperative Hours | Intravenous 0.9% Sodium Chloride | -0.89 | Standard Deviation 0.76 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intravenous 0.9% Sodium Chloride | 291 | |
| Overall Study | STARTED | Intravenous Acetaminophen | 289 | |
| Overall Study | COMPLETED | Intravenous 0.9% Sodium Chloride | 287 | |
| Overall Study | COMPLETED | Intravenous Acetaminophen | 283 | |
| Overall Study | NOT COMPLETED | Intravenous 0.9% Sodium Chloride | 4 | |
| Overall Study | NOT COMPLETED | Intravenous Acetaminophen | 6 |
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 | Intravenous Acetaminophen | 0 | 283 |
| Total, all-cause mortality | Intravenous 0.9% Sodium Chloride | 0 | 287 |
| Total, other adverse events | Intravenous Acetaminophen | 0 | 283 |
| Total, other adverse events | Intravenous 0.9% Sodium Chloride | 0 | 287 |
| Total, serious adverse events | Intravenous Acetaminophen | 0 | 283 |
| Total, serious adverse events | Intravenous 0.9% Sodium Chloride | 0 | 287 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32721009 | 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 |
|---|---|
| Intravenous Acetaminophen vs Intravenous 0.9% Sodium Chloride: Incidence of Postoperative Nausea and Vomiting | Trial comparisons |
| Intravenous Acetaminophen vs Intravenous 0.9% Sodium Chloride: deaths from any cause | Trial comparisons |
| Intravenous Acetaminophen vs Intravenous 0.9% Sodium Chloride: Incidence of Low Respiratory Function Event | Trial comparisons |
| Intravenous Acetaminophen vs Intravenous 0.9% Sodium Chloride: 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/NCT02156154
GET https://conductscience.org/api/trials/v1/NCT02156154/registered