Study to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Paracetamol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00344045

CN145-010

Details and patient eligibility

About

The main purpose is to evaluate the analgesic efficacy of 1g of intravenous (Iv) paracetamol versus i.v. placebo, administered every 6h, as measured by the reduction of the 24-hour cumulative dose of the opioid tramadol in the treatment of postoperative pain following total hip arthroplasty.

Enrollment: 86 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spinal anesth
• BMI 10-35
• No pain conditions/concom med may alter pain quantif.

Exclusion criteria

• Other add. surgery
• Liver/Renal function altered
• coagulation alterations
• Respir / Cardiac insufficiency
• Agents affecting microsomal syst

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Treatment:

Drug: Paracetamol

B

Placebo Comparator group

Treatment:

Drug: Placebo