Comparison of analgesic efficacy of intravenous paracetamol and intravenous dexketoprofen trometamol in multimodal analgesia after hysterectomy
Intravenous usage of paracetamol and dexketoprofen trometamol for analgesia after hysterectomy procedures in females
Hulya Basar
60 participants
Feb 23, 2009
Interventional
Conditions
Summary
We aimed to evaluate analgesic efficacy, opioid-sparing and opioid-related adverse effects of iv paracetamol and iv dexketoprofen trometamol in combination with iv morphine after abdominal hysterectomy. Double-blinded, randomized, placebo controlled, prospective study was designed.Sixty ASA I-II patients scheduled for abdominal hysterectomy were enrolled to study. Patients were randomly divided into three groups as paracetamol, dexketoprofen trometamol and placebo (0.9% NaCl). Intravenous patient-controlled analgesia morphine was used as a rescue analgesic in all groups. Pain scores, hemodynamic parameters, morphine consumption, patient satisfaction and side effects were evaluated. Normal distribution of continuous variables was assessed by Shapiro Wilk test. Significance of differences between groups was analyzed with One Way Analysis of Variances for means and with Kruskal Wallis for medians. Nominal data were evaluated by Pearson’s Chi-Square test. Visual Analog Scale (VAS) scores weren’t statistically significantly different among the groups in all evaluation times, but decrease in VAS scores was statistically significant after the evaluation at 12th hour in all groups. Total morphine consumption (morphine concentration=0.2mg/ml) in group paracetamol (72.3+/-38.0 ml) and dexketoprofen trometamol (69.3+/- 24.1 ml) was significantly lower than group placebo (129.3+/- 22.6 ml). Conclusions: Dexketoprofen trometamol and paracetamol didn’t cause significant change on pain scores but increased patients’ comfort. Although total morphine consumption was significantly decreased by both drugs, side effects were similar among the groups. According to results of the present study routine addition of dexketoprofen trometamol and paracetamol to PCA morphine after hysterectomies is not recommended.
Eligibility
Inclusion Criteria1
- Patients prepared for total abdominal hysterectomy operation,without severe renal, hepatic and cardiac disease, peptic ulcus and gastrointestinal bleeding, crohn’s disease or colitis ulcerosa, coagulation disorder, known allergic reaction to one of these drugs, chronic pain and routine analgesic usage, occurrence of complication during the operation were included into the study
Exclusion Criteria1
- Severe renal, hepatic and cardiac disease, peptic ulcus and gastrointestinal bleeding, crohn’s disease or colitis ulcerosa, coagulation disorder, known allergic reaction to the study drugs, chronic pain and routine analgesic usage, occurrence of complication during the operation were excluded.
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Interventions
ARM 1-1 gr of paracetamol (Perfalgan 10mg/ml 100 ml Flacon Bristol-Myers Squibb Labarotories, Renaudin Itxassou France) administered to 20 patients (Group I) by intravenous infusion in 15 minutes during the closure, and 1 gr of intravenous paracetamol administered at every 6 hours during the following 24 hours postoperatively.Paracetamol was not dilueted, as it is produced as a solution and marketing in bottles of 100ml. ARM 2-Dexketoprofen trometamol 50 mg/2 mL (Arveles 50 mg/2 ml Menarini International Italy) diluted in 100 mL of saline and administered to 20 patients(Group II), in 15 minutes by intravenous infusion during the closure and dose repeated at every 8 hours during the following 24 hours of postoperative period.After surgery, patient controlled analgesia equipment (Abbott Pain Management Provider, Abbott Laboratories, North Chicago, IL, USA) will be provided to every patient enrolled in this trial (60 patients) as resuce analgesia. It will be programmed for a bolus dose of 1mg of morphine then locked for 10 minutes (morphine concentration is 0.2mg /ml). The follow up period of the study was 24 hours as we evaluated acute postoperstive pain control
Locations(1)
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ACTRN12613000435785