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Lornoxicam vs. Paracetamol After Lower Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT01564680
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : March 28, 2012
Sponsor:
Information provided by (Responsible Party):
Dammam University

Brief 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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Other: placebo Drug: Paracetamol Drug: Lornoxicam Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Lornoxicam is More Effective Than Paracetamol as a Supplemental Analgesic After Lower Abdominal Surgery; A Randomized Controlled Trial
Study Start Date : March 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: Lornoxicam
Lornoxicam 16 mg will be given at skin closure and 8 mg will be given 12 hours postoperatively
Drug: Lornoxicam
16 mg at skin closure and 8 mg 12 hours postoperative
Other Name: xefo

Placebo Comparator: Control
Patients will receive normal saline at skin closure, at 6, 12, 18 hours postoperatively.
Other: placebo
normal saline
Other Name: 0.9 N sodium chloride

Experimental: Paracetamol
1 gm of paracetamol will be given at skin closure, 6, 12, 18 hours postoperatively
Drug: Paracetamol
IV paracetamol infusion
Other Name: perfalgan




Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 24 hours ]
    Postoperative pain scores measured by the verbal pain score (VPS)1, 2, 4, 8, 12 and 24 hours postoperatively.


Secondary Outcome Measures :
  1. Morphine consumption [ Time Frame: 24 hours ]
    pain was treated postoperatively using morphine patient-controlled analgesia. Morphine consumption was measured at 1, 2, 4, 8, 12 and 24 hours postoperatively

  2. Incidence of side-effects [ Time Frame: 24 hours ]
    incidence of side effects was measured at 1,2,4,8, 12, 24 hr postoperatively.



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564680


Locations
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Saudi Arabia
Dammam University, KFHU
Al-Khobar, EP, Saudi Arabia, 31952
Sponsors and Collaborators
Dammam University
Investigators
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Principal Investigator: Hany A Mowafi, MD UD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT01564680     History of Changes
Other Study ID Numbers: #201021
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012

Keywords provided by Dammam University:
Lower abdominal surgery
Paracetamol
Lornoxicam
Morphine

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Lornoxicam
Piroxicam
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action