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CLINICAL PROTOCOL FOR A MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF A SINGLE DOSAGE OF PARODOXIB SODIUM IV VS. A SINGLE DOSE OF KETOPROPHENE IV VS. ONE UNIQUE DOSAGE OF KETOROLACO IV VS. PLACEBO FOR THE TREATMENT OF PAIN AFTER A LAPAROSCOPIC COLLECISECTOMY.

CLINICAL PROTOCOL FOR A MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF A SINGLE DOSAGE OF PARODOXIB SODIUM IV VS. A SINGLE DOSE OF KETOPROPHENE IV VS. ONE UNIQUE DOSAGE OF KETOROLACO IV VS. PLACEBO FOR THE TREATMENT OF PAIN AFTER A LAPAROSCOPIC COLLECISECTOMY.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-077-02
Enrollment
Unknown
Registered
2002-12-12
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Parecoxib sodium Type of group
Parecoxib sodium 40 mg IV administered at the time of the last suture. Group name:placebo Type of group
Placebo saline solution administered at the time of the last suture

Sponsors

PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.- Men or women between 18 and 75 years of age. 2.- The patient has a body weight of 50 to 120 kg 3.- The patient requires an elective laparoscopic cholecystectomy. 4.- A procedure is anticipated under an ambulatory patient scheme.

Exclusion criteria

Exclusion criteria: The patient is scheduled to undergo some other surgical procedure that is expected to produce a greater degree of surgical traction than laparoscopic cholecystectomy alone. Acute preoperative pain other than biliary colic. A condition of chronic pain that requires chronic treatment and / or which, in the opinion of the Investigator, may affect pain assessments or the response to therapy. The patient has any type of cognitive impairment that, in the opinion of the Investigator, would impede participation in the study or adherence to the procedures required in the protocol.

Design outcomes

Primary

MeasureTime frame
Outcome name:The total amount of Fentanyl consumed in the first 6 hours after surgery Measure:The total amount of Fentanyl consumed in the first 6 hours after surgery Timepoints:6 first hours

Secondary

MeasureTime frame
Outcome name:The amount of Fentanyl consumed during the operation and during each of the first six hours after the operation Measure:The amount of Fentanyl consumed during the operation and during each of the first six hours after the operation Timepoints:6 first hours

Countries

Canada, Chile, Colombia, Mexico, Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)