ANZCTR - Registration

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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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

postoperative analgesia

Condition category

Condition code

Anaesthesiology

Pain management

Anaesthesiology

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]

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]

pain assesment with Visuel Analog scale (VAS)

Timepoint [1]

1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 hours

Primary outcome [2]

intraoperative analgesic consumption

Timepoint [2]

after recovery from anesthesia

Primary outcome [3]

postoperative analgesic consumption

Timepoint [3]

postoperative 24 hours

Secondary outcome [1]

Sedation score

Timepoint [1]

1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 hours

Secondary outcome [2]

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]

1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 hours

Secondary outcome [3]

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]

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?

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]

Turkey

State/province [1]

elazig

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Firat University Hospital

Address

Firat University Hospital
Anesthesiology and Reanimation Department
23119 Elazig

Country

Turkey

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Firat University Ethics Committee of Clinical Studies Conducted in Humans

Ethics committee address [1]

Firat University Ethics Committee 
Firat University Medicine Faculty
23119 Elazig

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

Approval date [1]

10/03/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

ayse Belin OZER

Address

Firat University Medicine Faculty
Anesthesiology and Reanimation Department
23119 Elazig

Country

Turkey

Phone

+90 424 2333555

Fax

+90 424 2388096

abelinozer@gmail.com

Contact person for scientific queries

Name

ayse belin ozer

Address

Firat University Medicine Faculty
Anesthesiology and Reanimation Department
23119 Elazig

Country

Turkey

Phone

+90 424 2333555

Fax

+90 424 2388096

abelinozer@gmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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