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Trial registered on ANZCTR


Registration number
ACTRN12612000317897
Ethics application status
Approved
Date submitted
15/03/2012
Date registered
21/03/2012
Date last updated
22/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the effects of dexketoprofen application before the operation or before the end of the operation on postoperative pain in nasal surgery.
Scientific title
Comparison of the effects of preoperative and intraoperative intravenous application of dexketoprofen on postoperative analgesia in septorhinoplasty patients: randomised double blind clinical trial
Secondary ID [1] 280129 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative analgesia 286057 0
Condition category
Condition code
Anaesthesiology 286250 286250 0 0
Pain management
Anaesthesiology 286269 286269 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group D50/0 (n=25): patients who received 100 ml SP containing 50 mg dexketoprofen as an infusion 30 minutes before the surgical incision and received 100 ml SP 30 minutes before the end of the surgical procedure.
Group D0/50 (n=25): patients who received 100 ml SP as an infusion 30 minutes before the surgical incision and received 100 ml SP containing 50 mg dexketoprofen 30 minutes before the end of the surgical procedure.
Group D25/25 (n=25): patients who received 100 ml SP containing 25 mg dexketoprofen as an infusion 30 minutes before the surgical incision and 30 minutes before the end of the surgical procedure.
Intervention code [1] 284466 0
Treatment: Drugs
Comparator / control treatment
plasebo
Group C (n=25): patients who received firstly 100 ml serum physiologic (SP) containing 0.9% NaCl as an infusion 30 minutes before anesthesia induction and secondly 30 minutes before the end of the surgical procedure.
Control group
Placebo

Outcomes
Primary outcome [1] 286735 0
pain assesment with Visuel Analog scale (VAS)
Timepoint [1] 286735 0
1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 hours
Primary outcome [2] 286752 0
intraoperative analgesic consumption
Timepoint [2] 286752 0
after recovery from anesthesia
Primary outcome [3] 286753 0
postoperative analgesic consumption
Timepoint [3] 286753 0
postoperative 24 hours
Secondary outcome [1] 296557 0
Sedation score
Timepoint [1] 296557 0
1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 hours
Secondary outcome [2] 296591 0
Postoperative nausea and vomiting was classified by using the following numerical scoring system, 0: no nausea or vomiting, 1: only nausea, 2: vomiting once in 30 minutes, 3: vomiting twice or more in 30 minutes. Patients with a nausea and vomiting score of 3 or the ones that have persistent nausea for more than two hours were assessed as severe nausea and vomiting and were administered 150 mg/kg metoclopramide intravenously
Timepoint [2] 296591 0
1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 hours
Secondary outcome [3] 296592 0
The patient satisfaction in 24 hours was evaluated according to the following 5 point scale; 1: very satisfied, 2: satisfied, 3: neither satisfied nor unsatisfied, 4: unsatisfied and 5: very unsatisfied.
Timepoint [3] 296592 0
postoperative 24 hours

Eligibility
Key inclusion criteria
ASA status I-II,
18-60 years old,
scheduled for septorhinoplasty
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with known heart, kidney, liver and hematological diseases, peptic ulcer and gastrointestinal bleeding, with allergic reaction to non-steroid anti-inflammatory drugs and chronic pain history and those who received analgesics in the last 24 hours were excluded into the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered envelopes ordered from a computer-generated random list
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4202 0
Turkey
State/province [1] 4202 0
elazig

Funding & Sponsors
Funding source category [1] 284912 0
Self funded/Unfunded
Name [1] 284912 0
Country [1] 284912 0
Primary sponsor type
Hospital
Name
Firat University Hospital
Address
Firat University Hospital
Anesthesiology and Reanimation Department
23119 Elazig
Country
Turkey
Secondary sponsor category [1] 283777 0
None
Name [1] 283777 0
Address [1] 283777 0
Country [1] 283777 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286896 0
Firat University Ethics Committee of Clinical Studies Conducted in Humans
Ethics committee address [1] 286896 0
Firat University Ethics Committee
Firat University Medicine Faculty
23119 Elazig
Ethics committee country [1] 286896 0
Turkey
Date submitted for ethics approval [1] 286896 0
Approval date [1] 286896 0
10/03/2011
Ethics approval number [1] 286896 0

Summary
Brief summary
Background: Postoperative analgesia is important because it prevents the adverse effects of pain. But it have been emphasized that postoperative analgesia’s timing is important in studies.
Objective: To study the effect of preoperative or intraoperative intravenous application of dexketoprofen on postoperative analgesia and patient comfort in patients undergoing septorhinoplasty.
Methods: A randomized, double-blind, placebo-controlled study. The study included 100 patients with ASA status I-II, 18-60 years old, scheduled for septorhinoplasty in University hospital. Patients with known heart, kidney, liver and hematological diseases, peptic ulcer and gastrointestinal bleeding, with allergic reaction to non-steroid anti-inflammatory drugs and chronic pain history and those who received analgesics in the last 24 hours were not included into the study. The patients were assigned to four groups according to a computer generated randomisation list by an independent anesthesiologist. Patients from group 50/0 got 50 mg dexketoprofen 30 minutes prior to the operation; patients from group 0/50 got 50 mg dexketoprofen 30 minutes before the end of the operation and patients from group 25/25 got 25 mg dexketoprofen both 30 minutes prior and 30 minutes before the end of the operation. Dexketoprofen was not applied to any of the patients from group C. Drug preparation, anestesia induction and maintenance and postoperative assesment were done by an anesthesiologist who did not known the patients’ group. All patients were administered patient-controlled analgesia. The patients’ visual analog scale (VAS), intraoperative and postoperative opioid consumption were primary outcomes. Patient satisfaction, sedation, nausea and vomiting and dyspepsia complaints were secondary outcomes and were recorded at 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 hours .
Results: The VAS, nausea and vomiting, sedation and patient satisfaction scores were lower in patients from all groups that had received dexketoprofen compared to the controls. There was no difference in intraoperative fentanyl consumption between the groups. The consumption of tramadol was significantly higher in group C compared to all other groups.
Conclusions: Dexketoprofen provides good postoperative analgesia and patient satisfaction if applied intravenously to septorhinoplasty patients. However, there is no significant difference between preoperative and intraoperative applications of dexketoprofen.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33916 0
Address 33916 0
Country 33916 0
Phone 33916 0
Fax 33916 0
Email 33916 0
Contact person for public queries
Name 17163 0
ayse Belin OZER
Address 17163 0
Firat University Medicine Faculty
Anesthesiology and Reanimation Department
23119 Elazig
Country 17163 0
Turkey
Phone 17163 0
+90 424 2333555
Fax 17163 0
+90 424 2388096
Email 17163 0
abelinozer@gmail.com
Contact person for scientific queries
Name 8091 0
ayse belin ozer
Address 8091 0
Firat University Medicine Faculty
Anesthesiology and Reanimation Department
23119 Elazig
Country 8091 0
Turkey
Phone 8091 0
+90 424 2333555
Fax 8091 0
+90 424 2388096
Email 8091 0
abelinozer@gmail.com

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