Lornoxicam vs. Paracetamol After Lower Abdominal Surgery

Postoperative Pain Clinical Trial

Official title:

Intravenous Lornoxicam is More Effective Than Paracetamol as a Supplemental Analgesic After Lower Abdominal Surgery; A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564680
• Other study ID #: #201021
• Status: Completed
• Phase: Phase 4
• First received: March 26, 2012
• Last updated: March 27, 2012
• Start date: March 2009
• Est. completion date: March 2011

Study information

• Verified date: March 2012
• Source: Dammam University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• placebo
normal saline

Drug:
• Paracetamol
IV paracetamol infusion
• Lornoxicam
16 mg at skin closure and 8 mg 12 hours postoperative

Locations

Country	Name	City	State
Saudi Arabia	Dammam University, KFHU	Al-Khobar	EP

Sponsors (1)

Lead Sponsor	Collaborator
Dammam University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Postoperative pain scores measured by the verbal pain score (VPS)1, 2, 4, 8, 12 and 24 hours postoperatively.	24 hours	No
Secondary	Morphine consumption	pain was treated postoperatively using morphine patient-controlled analgesia. Morphine consumption was measured at 1, 2, 4, 8, 12 and 24 hours postoperatively	24 hours	No
Secondary	Incidence of side-effects	incidence of side effects was measured at 1,2,4,8, 12, 24 hr postoperatively.	24 hours	Yes