Clinical trial NCT02092012: Comparison of Preemptive Analgesic Effects of Dexketoprofen Versus Dexmedetomidine on Abdominal Hysterectomy Patients
Official title: Comparison of Preemptive Analgesic Effects of Dexketoprofen Versus Dexmedetomidine on the Patients That is Undergoing Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Keywords: postoperative pain
dexketoprofen trometamol
dexmedetomidine
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: postoperative 1 day
Secondary outcomes:
measure: analgesic consumption
timeFrame: postoperative 1 day
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes Univercity Medicine Faculty
Study officials:
affiliation: erciyes univercity medicine faculty
name: selda kayaaltı, resident
role: PRINCIPAL_INVESTIGATOR
References: