Trial · NCT04641338
Fixed Combination of Dipyrone and Codeine for Controlling Pain After Pelvic-abdominal Surgery
NCT04641338, Phase 3, Completed, Brazilian Clinical Research Institute
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Fixed Combination of Dipyrone and Codeine for Controlling Pain After Pelvic-abdominal Surgery. Trials, record NCT04641338. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04641338
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fixed Combination of Dipyrone and Codeine for Controlling Pain After Pelvic-abdominal Surgery
- NCT number
- NCT04641338
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 491 participants, actual
- Lead sponsor
- Brazilian Clinical Research Institute
- Conditions
- Pain, Postoperative
- Interventions
- Fixed dose combination Dipyrone and Codeine, Dipyrone, Codeine
- First posted
- 2020-11-23
- Last updated
- 2026-05-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants achieving at least 50% of maximum pain relief within 6 hours | 6 hours | Proportion of participants achieving at least 50% of maximum pain relief within 6 hours after first drug administration, through the assessment of total pain relief (TOTPAR) after first drug administration. TOTPAR is calculated from the result of the 5-point categorical pain relief scale (adapted PAR scale, with the 5 categories: 1-no relief, 2-mild relief, 3-moderate relief, 4-a lot of relief, and 5-complete relief). The PAR will be evaluated 30 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours after drug administration, so that the TOTPAR can take into account the progress of pain relief at 8 different timepoints. |
| Secondary | Pain assessment by the visual analogic scale score | 6 hours | The average visual analogic scale score (visual analogic scale from 0 to 10 cm, where 0 = no pain and 10 = the worst imaginable pain) measured at rest and during handling in subsequent medication. |
| Secondary | Proportion of participants who achieve at least 50% pain reduction | 6 hours | Assessment of the proportion of participants who achieve at least 50% pain reduction within 6 hours, through assessment of SPID (sum of the pain intensity difference) after the first dose of study drugs; |
| Secondary | Assessment of complete pain relief | 72 hours | Assessment of complete pain relief by verbal scale assessment of pain relief (VRS where 0 = no pain relief, 1 = mild pain relief, 2 = moderate pain relief, 3 = good pain relief, and 4 = excellent pain relief). |
| Secondary | Time to pain relief | During hospitalization | Median time to pain relief |
| Secondary | Assessment of satisfaction with treatment by the participant | 14 days | Assessment of satisfaction with treatment by the participant using a standard categorical rating scale: Patient-reported global evaluation of Eficacy (PGE) scale of 5-points where 0=poor, 1=fair, 2=good , 3=very good, and 5=excellent response to therapy). |
| Secondary | Presence of adverse events | 14 days |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
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/NCT04641338
GET https://conductscience.org/api/trials/v1/NCT04641338/registered