Back to resultsIntravenous Paracetamol Compared Dexketoprofen for Postoperative Analgesia After Septoplasty
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Paracetamol
Dexketoprofen
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Paracetamol, Dexketoprofen, postoperative pain, septoplasty
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Paracetamol
Dexketoprofen
Arm Description
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
50 mg dexketoprofen received intravenous bolus 15 minutes after anesthetic induction and at the postoperative 8 th,16 th and 24 th hours.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Cumulative tramadol consumption during postoperative 24 hours.
Cumulative tramadol consumption was recorded during postoperative 24 hours.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02602197
Brief Title
Intravenous Paracetamol Compared Dexketoprofen for Postoperative Analgesia After Septoplasty
Official Title
The Efficacy of Intravenous Paracetamol Versus Dexketoprofen for Postoperative Pain Management After Septoplasty: A Prospective Randomized Double Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Paracetamol, Dexketoprofen, postoperative pain, septoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paracetamol
Arm Type
Active Comparator
Arm Description
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
Arm Title
Dexketoprofen
Arm Type
Active Comparator
Arm Description
50 mg dexketoprofen received intravenous bolus 15 minutes after anesthetic induction and at the postoperative 8 th,16 th and 24 th hours.
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Parol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen
Other Intervention Name(s)
Arveles
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from pain scores until postoperative 24 hours
Description
Pain scores as measured by Visual Analog Scale (VAS) at 15 and 30 minutes, 1h, 2h, 4h, 6h, 12h, and 24 h after surgery
Time Frame
Pain scores recorded during postoperative 24 hours.
Secondary Outcome Measure Information:
Title
Cumulative tramadol consumption during postoperative 24 hours.
Description
Cumulative tramadol consumption was recorded during postoperative 24 hours.
Time Frame
First postoperative 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Intravenous Paracetamol Compared Dexketoprofen for Postoperative Analgesia After Septoplasty
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