Comparison of Preemptive Analgesic Effects of Dexketoprofen Versus Dexmedetomidine on Abdominal Hysterectomy Patients

Phase 4

• Conditions: Pain
• Interventions: Drug: dexketoprofen trometamol; Drug: Dexmedetomidine

• Registration Number: NCT02092012
• Lead Sponsor: TC Erciyes University

Brief Summary

The aim of this study is to investigate comparison of preemptive analgesic effects of dexketoprofen versus dexmedetomidine on the patients that is undergoing abdominal hysterectomy.

Detailed Description

Abdominal hysterectomy is associated with moderate to severe postoperative pain which has unfavorable effects on patient's recovery and procedure's outcome. Administration of opioid analgesics is routinely practiced but is limited with dose-related adverse effects.\[1\] Within this concept, combining an opioid with different analgesics acting by different mechanisms as multimodal analgesia is recommended for effective post-operative pain control Dexketoprofen trometamol is a newly developed, centrally acting NSAID with potency similar to that of μ-opioid agonists.\[4\] In a number of studies in different pain models, it has been proven to have a good analgesic efficacy and tolerability.

Dexmedetomidine is a highly selective α2 adrenoceptor agonist that provides sedation, analgesia, and sympatholysis. These characteristics make dexmedetomidine useful anesthetic adjunct during operation. Previous studies report that intravenous has a definitive role in postoperative analgesia through the reduction of opioid consumption The aim of this prospective randomized, double-blind study is to evaluate the analgesic efficacy and opioid sparing effects of preemptive single dose of dexketoprofen trometamol in comparison with dexmedetomidine in the patients abdominal hysterectomy , over a 24-hour (h) investigation period.

After institutional approval and informed consent had been obtained, 60 patients scheduled for abdominal hysterectomy randomly allocated into two equal groups. Patients received ıv dexketoprofen 50 mg (Group I), ıv dexmedetomidine 1mcg/kg (Group II) after anesthesia induction and 10 minutes (min) before surgical incision. Patient controlled analgesia was supplied postoperatively using morphine. Hemodynamics, visual analogue scale (VAS), sedation score, morphine consumption, and side effects were recorded every and at 2, 6, 12 and 24 h after surgery.

Study Timeline

• Status Verified: 2014-03
• Study Start: 2014-03
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-19
• Last Update Submitted: 2014-03-20
• Last Update Posted: 2014-03-21
• Primary Completion: 2014-06
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 18- 65 year female
• Scheduled for elective abdominal hysterectomy
• No known allergies to drugs
• ASA I-II patients

Exclusion Criteria

• Pregnancy
• Drug or alcohol abuse
• History of allergic reaction to any of the study drugs
• Ongoing opioid, and non-steroidal anti-inflammatory
• Analgesic therapy
• Cardiac, respiratory, hepatic and/or renal failure
• History of peptic ulcer disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexketoprofen trometamol	dexketoprofen trometamol	ıv 50 mg dexketoprofen trometamol after anesthesia induction
dexmedetomidine	Dexmedetomidine	ıv 1 mcg/kg dexmedetomidine after anaesthesia induction

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	postoperative 1 day	Visual Analog Scale on rest and movement record

Secondary Outcome Measures

Name	Time	Method
analgesic consumption	postoperative 1 day	morphine consumption with patient controlled analgesia record

Trial Locations

Locations (1)

Erciyes Univercity Medicine Faculty; 🇹🇷 Kayseri, Turkey