Intravenous Paracetamol Compared Dexketoprofen for Postoperative Analgesia After Septoplasty
The Efficacy of Intravenous Paracetamol Versus Dexketoprofen for Postoperative Pain Management After Septoplasty: A Prospective Randomized Double Blind Study
1 other identifier
interventional
2
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 postoperative-pain
Started Aug 2013
Longer than P75 for phase_3 postoperative-pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 31, 2015
CompletedFirst Posted
Study publicly available on registry
November 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedNovember 11, 2015
November 1, 2015
2.3 years
March 31, 2015
November 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Cumulative tramadol consumption during postoperative 24 hours.
First postoperative 24 hours
Study Arms (2)
Paracetamol
ACTIVE COMPARATOR1 gr paracetamol received intravenously bolus 15 minutes after anesthetic induction and at the postoperative 6 th,12 th, 18 th and 24 th hours
Dexketoprofen
ACTIVE COMPARATOR50 mg dexketoprofen received intravenous bolus 15 minutes after anesthetic induction and at the postoperative 8 th,16 th and 24 th hours.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of clotting disorders or blood dyscrasias,
- Gastrointestinal ulcer or chronic dyspepsia,
- History of allergy to the study drugs,
- Active bleeding or bleeding disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
March 31, 2015
First Posted
November 11, 2015
Study Start
August 1, 2013
Primary Completion
December 1, 2015
Study Completion
February 1, 2016
Last Updated
November 11, 2015
Record last verified: 2015-11