Trial · NCT01608308
Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery
NCT01608308, Not applicable, Completed, The University of Texas Health Science Center, Houston; results first posted 2015-09-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery. Trials, record NCT01608308. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01608308
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery
- NCT number
- NCT01608308
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 62 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Chronic Sinusitis
- Interventions
- IV Acetaminophen, Placebo
- First posted
- 2012-05-31
- Last updated
- 2015-10-16
- Results first posted
- 2015-09-04
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale | 15 minutes and 120 minutes Post-Operatively | VAS is a validated, self-reported data sheet assessing average pain intensity. Possible scores range from 0 (no pain) to 10 (highest level of pain). |
| Secondary | Total Doses of Postoperative Opiate (Morphine) Use | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | The total amount of morphine utilized in Postoperative Acute Care Unit (PACU) will be recorded. One dose is a 1mg bolus of morphine. |
| Secondary | Number of Participants Who Received Intraoperative Supplemental Fentanyl | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | Number of participants who received intraoperative supplemental fentanyl. The decision to administer fentanyl is based on hemodynamic changes, such as increasing blood pressure and heart rate. |
| Secondary | Number of Participants Who Experienced Postoperative Morbidity (Nausea) | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | Post-operative nausea will be monitored and measured through direct observation and nursing clinical record |
| Secondary | Postoperative Vital Sign (Systolic Blood Pressure) | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery. |
| Secondary | Postoperative Vital Sign (Diastolic Blood Pressure) | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery. |
| Secondary | Postoperative Vital Sign (Pulse) | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery. |
| Secondary | Postoperative Vital Sign (Temperature) | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery. |
| Secondary | Postoperative Vital Sign (Respiratory Rate) | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale | 15 minutes and 120 minutes Post-Operatively | At the 15 minute time point, data was obtained for 24 participants in the acetaminophen group and 26 participants in the control group. For the 120 minute time point, data was obtained for 7 participants in the acetaminophen group and 11 participants in the control group. | units on a scale | MEDIAN |
| SECONDARY | Total Doses of Postoperative Opiate (Morphine) Use | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | doses | MEDIAN | |
| SECONDARY | Number of Participants Who Received Intraoperative Supplemental Fentanyl | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | participants | NUMBER | |
| SECONDARY | Number of Participants Who Experienced Postoperative Morbidity (Nausea) | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | participants | NUMBER | |
| SECONDARY | Postoperative Vital Sign (Systolic Blood Pressure) | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | mmHg | MEAN | |
| SECONDARY | Postoperative Vital Sign (Diastolic Blood Pressure) | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | mmHg | MEAN | |
| SECONDARY | Postoperative Vital Sign (Pulse) | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | beats per minute | MEAN | |
| SECONDARY | Postoperative Vital Sign (Temperature) | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | Fahrenheit | MEAN | |
| SECONDARY | Postoperative Vital Sign (Respiratory Rate) | During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) | breaths per minute | MEAN |
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 |
|---|---|---|---|---|---|
| Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale | IV Acetaminophen | 15 minutes (n=24, 26) | 0 | Inter-Quartile Range 0 to 3 | units on a scale |
| Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale | Control | 15 minutes (n=24, 26) | 0 | Inter-Quartile Range 0 to 4 | units on a scale |
| Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale | IV Acetaminophen | 120 minutes (n=7, 11) | 0 | Inter-Quartile Range 0 to 2 | units on a scale |
| Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale | Control | 120 minutes (n=7, 11) | 2 | Inter-Quartile Range 0 to 4 | units on a scale |
| Total Doses of Postoperative Opiate (Morphine) Use | IV Acetaminophen | 1.5 | Inter-Quartile Range 1 to 2.5 | doses | |
| Total Doses of Postoperative Opiate (Morphine) Use | Control | 2.5 | Inter-Quartile Range 2 to 4 | doses | |
| Number of Participants Who Received Intraoperative Supplemental Fentanyl | IV Acetaminophen | 9 | participants | ||
| Number of Participants Who Received Intraoperative Supplemental Fentanyl | Control | 4 | participants | ||
| Number of Participants Who Experienced Postoperative Morbidity (Nausea) | IV Acetaminophen | 13 | participants | ||
| Number of Participants Who Experienced Postoperative Morbidity (Nausea) | Control | 10 | participants |
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 | IV Acetaminophen | 31 | |
| Overall Study | STARTED | Control | 31 | |
| Overall Study | COMPLETED | IV Acetaminophen | 31 | |
| Overall Study | COMPLETED | Control | 29 | |
| Overall Study | NOT COMPLETED | IV Acetaminophen | 0 | |
| Overall Study | NOT COMPLETED | Control | 2 |
Source ClinicalTrials.gov
Adverse events2
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 | Surgical and medical procedures | IV Acetaminophen | 13 | 31 | |
| other | Nausea | Surgical and medical procedures | Control | 10 | 29 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IV Acetaminophen | ||
| Total, all-cause mortality | Control | ||
| Total, other adverse events | IV Acetaminophen | 13 | 31 |
| Total, other adverse events | Control | 10 | 29 |
| Total, serious adverse events | IV Acetaminophen | 0 | 31 |
| Total, serious adverse events | Control | 0 | 29 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28542675 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IV Acetaminophen vs Control: Number of Participants Who Received Intraoperative Supplemental Fentanyl | Trial comparisons |
| IV Acetaminophen vs Control: Number of Participants Who Experienced Postoperative Morbidity (Nausea) | Trial comparisons |
| IV Acetaminophen vs Control: 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/NCT01608308
GET https://conductscience.org/api/trials/v1/NCT01608308/registered