Fixed Combination of Dipyrone and Codeine for Controlling Pain After Pelvic-abdominal Surgery (NCT04641338) | Clinical Trial Compass
CompletedPhase 3
Fixed Combination of Dipyrone and Codeine for Controlling Pain After Pelvic-abdominal Surgery
Brazil491 participantsStarted 2023-03-16
Plain-language summary
Phase III clinical trial, multicentre, superiority, randomized, open, parallel groups, with active control and use of postoperative oral medication (multiple doses of medication).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men or women aged 18 years or older;
* Be able to sign the ICF approved by the IEC and to perform and understand all the study procedures and instructions;
* Show post-anesthesia recovery with a score greater than or equal to 8 on the modified Aldrete and Kroulik Scale;
* Experience pain intensity according to the visual analogue scale (VAS) of 3.0 to 10 cm (moderate to severe pain) immediately after surgery;
* Have an elective open abdominal-pelvic surgery scheduled, not due to malignant neoplasm, to be performed within 4 weeks of screening;
* Estimated hospital stay for at least 48 hours after the procedure.
Exclusion Criteria:
* Surgical complications during participant enrollment in the research;
* Surgery with indication for treatment of confirmed or suspected malignant neoplasm;
* Chronic use of any non-steroidal anti-inflammatory drugs;
* Suspected paralytic ileus or intestinal obstruction;
* Inability to use oral drugs postoperatively;
* Videolaparoscopic surgery;
* History of chronic and current use of opioids or other analgesics;
* Use of concomitant modalities of intravenous or neuraxial analgesia (spinal and epidural) with placement of an epidural catheter for use in the postoperative period, or regional blockade, where the expected duration of analgesia administered intravenously or neuroaxially is maintained after 24 hours of the surgical procedure or randomization, whichever occurs first;
* Use of immunosuppressive therapy in the last 2…
What they're measuring
1
Proportion of participants achieving at least 50% of maximum pain relief within 6 hours