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Comparison of the effects of dexketoprofen application before the operation or before the end of the operation on postoperative pain in nasal surgery.

Comparison of the effects of preoperative and intraoperative intravenous application of dexketoprofen on postoperative analgesia in septorhinoplasty patients: randomised double blind clinical trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000317897
Enrollment
100
Registered
2012-03-21
Start date
2011-04-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 de

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.

Sponsors

Firat University Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

ASA status I-II, 18-60 years old, scheduled for septorhinoplasty

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026