Intravenous Paracetamol Compared Dexketoprofen for Postoperative Analgesia After Septoplasty

Study Overview
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Brief Summary
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The investigators conducted a prospective, randomized, double blind study to compare the effectiveness of intravenous paracetamol and dexketoprofen for preventing pain during first 24 hours postoperative period in adult patient undergoing septoplasty.

Detailed Description
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Postoperative pain scores as measured by Visual Analog Scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60 minutes and 2th, 4th, 6th, 12th and 24th hours postoperatively.

Official Title
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The Efficacy of Intravenous Paracetamol Versus Dexketoprofen for Postoperative Pain Management After Septoplasty: A Prospective Randomized Double Blind Study

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Dexketoprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: After patient's inform consent was approved, a total of 70 ASA (American Society of Anesthesiology) physical status I and II adult patients age 18 to 65 undergoing septoplasty were planned include the study. Exclusion Criteria: History of clotting disorders or blood dyscrasias, Gastrointestinal ulcer or chronic dyspepsia, History of allergy to the study drugs, Active bleeding or bleeding disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracetamol<br>1 gr paracetamol received intravenously bolus 15 minutes after anesthetic induction and at the postoperative 6 th,12 th, 18 th and 24 th hours | Drug: Paracetamol<br>* After anesthetic induction, the first I.V bolus injections of 1 gr paracetamol (total amount of 100 ml) were given during 15 minutes and then repeated every 6 h until 24 h postoperative period.<br>* Other names: Parol;|
| Active Comparator: Dexketoprofen<br>50 mg dexketoprofen received intravenous bolus 15 minutes after anesthetic induction and at the postoperative 8 th,16 th and 24 th hours. | Drug: Dexketoprofen<br>* After anesthetic induction, the first I.V bolus injections of 50 mg Dexketoprofen (premixed with 0.9 % sodium chloride to total amount of 100 ml) were given during 15 minutes and then repeated every 8 h until 24 h postoperative period.<br>* Other names: Arveles;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from pain scores until postoperative 24 hours | Pain scores as measured by Visual Analog Scale (VAS) at 15 and 30 minutes, 1h, 2h, 4h, 6h, 12h, and 24 h after surgery | Pain scores recorded during postoperative 24 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative tramadol consumption during postoperative 24 hours. | Cumulative tramadol consumption was recorded during postoperative 24 hours. | First postoperative 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paracetamol, Dexketoprofen, postoperative pain, septoplasty