Comparison · NCT01608308-704e6757
IV Acetaminophen vs Control: Number of Participants Who Received Intraoperative Supplemental Fentanyl
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. IV Acetaminophen vs Control: Number of Participants Who Received Intraoperative Supplemental Fentanyl. Trial comparisons, record NCT01608308-704e6757. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01608308-704e6757
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.29 | 0.161 | 0.466 | wilson | |
| Risk in group 2 | 0.138 | 0.055 | 0.306 | wilson | |
| Risk difference, group 1 minus group 2 | 0.152 | -0.0594 | 0.347 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.1 | 0.727 | 6.1 | log | |
| Odds ratio, group 1 over group 2 | 2.56 | 0.69 | 9.47 | log | |
| Number needed to treat, for one more participant with the outcome on IV Acetaminophen than on Control | 6.56 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | IV Acetaminophen | The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses. | 9 | 31 | OG000 |
| Group 2 | Control | The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen. | 4 | 29 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Received Intraoperative Supplemental Fentanyl
- Description
- 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.
- Time frame
- During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
- Population
Source ClinicalTrials.gov
Trial
- Title
- Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery
- NCT number
- NCT01608308
- Phases
- NA
- Conditions
- Chronic Sinusitis
- Interventions
- IV Acetaminophen, Placebo
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Results first posted
- 2015-09-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01608308?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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