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Comparison Efficiency of Oral Etoricoxib Versus Intravenous Fentanyl on Post Operative Pain in Curettage Under TIVA

Not Applicable
Completed
Conditions
Abnormal Uterine Bleeding
Interventions
Procedure: fractional curettage
Registration Number
NCT03697733
Lead Sponsor
Rajavithi Hospital
Brief Summary

Comparison of the efficiency of oral Etoricoxib versus intravenous Fentanyl on post operative Pain in curettage under TIVA: A randomized controlled trial

Detailed Description

Fractional Curettage is the most widely used for diagnostic and treatment abnormal uterine bleeding. The patient categorize post-operative pain as mild to moderate. Therefore, the effective analgesic added on intraoperative and post-operative is the most important factor in patient's satisfaction, patient well co-operation, shortness time of operation, decrease unpleasant symptoms and rapid recovery. However, there are many anesthetic technique that can be used to relive pain in the operation such as local anesthesia, total intravenous anesthesia, regional anesthesia or oral analgesic drugs.

Intravenous Fentanyl is an short acting opioid. It has a fast onset of action within 2 minutes and short duration of action 30-60 minutes. Respiratory depression, hypotension and bradycardia are adverse effects that might delayed discharge especially in one day surgery e.g. fractional curettage. Etoricoxib is an oral COX-2 specific inhibitor which can be used to relieve the pain. The onset of analgesia can be occurred within 24 minutes which peak plasma level within 60 minutes. There are many empirical evidences to support the results of post-operative pain after used oral Etoricoxib or intravenous Fentanyl. However, there are less evidences to support efficiency of oral Etoricoxib versus intravenous Fentanyl on post-operative Pain in fractional curettage under TIVA

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
60
Inclusion Criteria
  • Women who having abnormal uterine bleeding undergoing fractional curettage under TIVA
Exclusion Criteria
  • Women who have opioid or NSAIDs allergy
  • Women who disagree to participate in this study
  • Women who have history of gastrointestinal bleeding or ulcer
  • Women who have abnormal kidney function
  • Women who can't understand Thai language
  • Women who have American Society of Anesthesiologists [ASA] above 2
  • Women who have been used NSAIDs in 48 hours or often used NSAIDs

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Oral Etoricoxib groupfractional curettageSubjects will receive oral Etoricoxib120 mg 30 minutes before fractional curettage then added intravenous Propofol 2 mg/kg when start the procedure
Intravenous Fentanyl groupfractional curettageSubjects will receive oral placebo \[folic acid\] 1 tab 30 minutes before the procedure then added intravenous Propofol 2 mg/kg and Intravenous Fentanyl 1 microgram/kg when start the procedure
Primary Outcome Measures
NameTimeMethod
post operative painat 15 minute after operation

Compare efficacy of oral Etoricoxib and intravenous Fentanyl for post fractional curettage pain by using a visual analog pain scale \[Score 0-10\]

Secondary Outcome Measures
NameTimeMethod
The first time pain reliever was used in post operationwithin 60 minutes after the procedure

Record the first time patient asked for post operative pain reliver or visual analog pain score \> 5

Adverse effect from the drugs during and post operationsince subject receive drugs until 60 minutes after procedure

Record subject experience of the following symptoms : nausea and vomiting ,dizziness, drowsiness ,allergic reaction ,chest pain ,and gastrointestinal bleeding or gastrointestinal discomfort

Amount of intravenous Propofol used in the procedureonly intraoperative time

Record dose of intravenous Propofol that used in TIVA

Trial Locations

Locations (1)

Rajavithi Hospital

🇹🇭

Bangkok, Thailand

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