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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02092012
Enrollment
60
Registered
2014-03-19
Start date
2014-03-31
Completion date
2014-07-31
Last updated
2014-03-21

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

Conditions

Pain

Keywords

postoperative pain, dexketoprofen trometamol, dexmedetomidine

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.

Interventions

ıv 50 mg dexketoprofen trometamol after anaesthesia induction

DRUGDexmedetomidine

ıv 1 mcg/kg dexmedetomidine after anaesthesia induction

Sponsors

TC Erciyes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scalepostoperative 1 dayVisual Analog Scale on rest and movement record

Secondary

MeasureTime frameDescription
analgesic consumptionpostoperative 1 daymorphine consumption with patient controlled analgesia record

Countries

Turkey (Türkiye)

Contacts

Primary Contactselda kayaaltı, resident
drselda@hotmail.com+905558168918
Backup Contactfatih ugur, assoc
ugurf@erciyes.edu.tr+905359730073

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026