Lornoxicam vs. Paracetamol After Lower Abdominal Surgery

Imam Abdulrahman Bin Faisal University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Other: placebo; Drug: Paracetamol; Drug: Lornoxicam

Study type: Interventional

Funder types: Other

Identifiers

NCT01564680

#201021

Details and patient eligibility

About

Background: The aim of this prospective, randomized, double-blind study is to determine the most effective supplemental analgesic, paracetamol or lornoxicam for postoperative pain relief after lower abdominal surgery.

Methods: Sixty patients scheduled for lower abdominal surgery under general anesthesia were randomly allocated to receive either isotonic saline (Control group), intravenous paracetamol 1 g every 6 h (Paracetamol group) or lornoxicam 16 mg then 8 mg after 12 h (Lornoxicam group). Additionally pain was treated postoperatively using morphine patient-controlled analgesia. Postoperative pain scores measured by the verbal pain score (VPS), morphine consumption and the incidence of side effects were measured at 1, 2, 4, 8, 12 and 24 hours postoperatively.

Enrollment: 60 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• lower abdominal surgery

Exclusion criteria

• body weight more than 150% of their ideal body weight
• history of significant cardiac, pulmonary, renal, hepatic or hematological disease; chronic drug or alcohol abuse; hypersensitivity to any of the studied drugs; bronchial asthma; gastritis or peptic ulcer; and pregnancy
• patients who received any analgesic drug a day before surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Lornoxicam

Experimental group

Description:

Lornoxicam 16 mg will be given at skin closure and 8 mg will be given 12 hours postoperatively

Treatment:

Drug: Lornoxicam

Control

Placebo Comparator group

Description:

Patients will receive normal saline at skin closure, at 6, 12, 18 hours postoperatively.

Treatment:

Other: placebo

Paracetamol

Experimental group

Description:

1 gm of paracetamol will be given at skin closure, 6, 12, 18 hours postoperatively

Treatment:

Drug: Paracetamol