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Intravenous Paracetamol Compared Dexketoprofen for Postoperative Analgesia After Septoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02602197
Recruitment Status : Unknown
Verified November 2015 by Esra Caliskan, Baskent University.
Recruitment status was:  Active, not recruiting
First Posted : November 11, 2015
Last Update Posted : November 11, 2015
Information provided by (Responsible Party):
Esra Caliskan, Baskent University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Paracetamol Drug: Dexketoprofen Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Intravenous Paracetamol Versus Dexketoprofen for Postoperative Pain Management After Septoplasty: A Prospective Randomized Double Blind Study
Study Start Date : August 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : February 2016

Arm Intervention/treatment
Active Comparator: Paracetamol
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
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.
Other Name: Parol

Active Comparator: Dexketoprofen
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
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.
Other Name: Arveles

Primary Outcome Measures :
  1. Change from pain scores until postoperative 24 hours [ Time Frame: Pain scores recorded during 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

Secondary Outcome Measures :
  1. Cumulative tramadol consumption during postoperative 24 hours. [ Time Frame: First postoperative 24 hours ]
    Cumulative tramadol consumption was recorded during postoperative 24 hours.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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Responsible Party: Esra Caliskan, Associated Professor, Baskent University Identifier: NCT02602197    
Other Study ID Numbers: KA 13/100
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015
Keywords provided by Esra Caliskan, Baskent University:
postoperative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Dexketoprofen trometamol
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents