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

Efficiency of Oral Etoricoxib Versus Intravenous Fentanyl On Post Operative Pain In Curettage Under TIVA : A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Abnormal Uterine Bleeding
• Intervention / Treatment: Procedure: fractional curettage

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Etoricoxib group; Subjects will receive oral Etoricoxib120 mg 30 minutes before fractional curettage then added intravenous Propofol 2 mg/kg when start the procedure	Procedure: fractional curettage; Fractional curettage under TIVA by used oral Etoricoxib120 mg at 30 minutes before fractional curettage and then added intravenous Propofol 2 mg/kg when start the procedure or Intravenous Fentanyl 1 microgram/kg and Propofol 2 mg/kg when start the procedure
Placebo Comparator: Intravenous Fentanyl group; Subjects 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	Procedure: fractional curettage; Fractional curettage under TIVA by used oral Etoricoxib120 mg at 30 minutes before fractional curettage and then added intravenous Propofol 2 mg/kg when start the procedure or Intravenous Fentanyl 1 microgram/kg and Propofol 2 mg/kg when start the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain	Compare efficacy of oral Etoricoxib and intravenous Fentanyl for post fractional curettage pain by using a visual analog pain scale [Score 0-10]	at 60 minute after operation
post operative pain	Compare efficacy of oral Etoricoxib and intravenous Fentanyl for post fractional curettage pain by using a visual analog pain scale [Score 0-10]	at 30 minute after operation
post operative pain	Compare efficacy of oral Etoricoxib and intravenous Fentanyl for post fractional curettage pain by using a visual analog pain scale [Score 0-10]	at 15 minute after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effect from the drugs during and post operation	Record subject experience of the following symptoms : nausea and vomiting ,dizziness, drowsiness ,allergic reaction ,chest pain ,and gastrointestinal bleeding or gastrointestinal discomfort	since subject receive drugs until 60 minutes after procedure
Amount of intravenous Propofol used in the procedure	Record dose of intravenous Propofol that used in TIVA	only intraoperative time
The first time pain reliever was used in post operation	Record the first time patient asked for post operative pain reliver or visual analog pain score > 5	within 60 minutes after the procedure

Collaborators and Investigators

• Sponsor: Rajavithi Hospital
• Investigators: Principal Investigator: apichaya buraputthananon, Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Uterine Diseases; Hemorrhage; Pain, Postoperative; Uterine Hemorrhage
• Other Study ID Numbers: Etovsfen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No