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

Pain Clinical Trial

Official title:

Comparison of Preemptive Analgesic Effects of Dexketoprofen Versus Dexmedetomidine on the Patients That is Undergoing Abdominal Hysterectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02092012
• Other study ID #: 2013/489
• Status: Recruiting
• Phase: Phase 4
• First received: March 18, 2014
• Last updated: March 20, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: March 2014
• Source: TC Erciyes University
• Contact: selda kayaalti, resident
• Phone: +905558168918
• Email: drselda[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• dexketoprofen trometamol
iv 50 mg dexketoprofen trometamol after anaesthesia induction
• Dexmedetomidine
iv 1 mcg/kg dexmedetomidine after anaesthesia induction

Locations

Country	Name	City	State
Turkey	Erciyes Univercity Medicine Faculty	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	Visual Analog Scale on rest and movement record	postoperative 1 day	No
Secondary	analgesic consumption	morphine consumption with patient controlled analgesia record	postoperative 1 day	No