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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Lornoxicam 16 mg will be given at skin closure and 8 mg will be given 12 hours postoperatively
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 Name: 0.9 N sodium chloride
1 gm of paracetamol will be given at skin closure, 6, 12, 18 hours postoperatively
IV paracetamol infusion
Other Name: perfalgan
- 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.
- 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
- Incidence of side-effects [ Time Frame: 24 hours ]incidence of side effects was measured at 1,2,4,8, 12, 24 hr postoperatively.
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
|Dammam University, KFHU|
|Al-Khobar, EP, Saudi Arabia, 31952|
|Principal Investigator:||Hany A Mowafi, MD||UD|