NCT04641338

Fixed Combination of Dipirone and Codeine Compared to the Isolated Use of Dipyrone and Codeine in Controlling Pain After Pelvic-abdominal Surgery.

Randomized, Open, Multicentre, National Superiority Clinical Trial to Assess the Combination of Fixed Dosage of Dipyrone and Codeine Compared to the Isolated Use of Components in the Control of Moderate to Severe Pain After Open Pelvic-abdominal Surgery.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 491 (actual)
• Sponsor: Brazilian Clinical Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase III clinical trial, multicentre of superiority, randomized, open, parallel groups, with active control and use of postoperative oral medication (multiple doses of medication).

Detailed description

The main objective is to evaluate the effectiveness and safety of the association in relation to the isolated use of medicines.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Fixed dose combination Dipyrone and Codeine	Fixed dose combination: dipyrone 1000 mg + codeine 30 mg every 6 hours if necessary.
DRUG	Dipyrone	use of 1000 mg dipyrone every 6 hours if necessary.
DRUG	Codeine	30 mg codeine every 6 hours if necessary.

Timeline

• Start date: 2023-03-16
• Primary completion: 2024-03-15
• Completion: 2024-05-17
• First posted: 2020-11-23
• Last updated: 2024-06-27

Locations

3 sites across 1 country: Brazil