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

Primary Purpose

Abnormal Uterine Bleeding

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
fractional curettage
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abnormal Uterine Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Rajavithi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral Etoricoxib group

Intravenous Fentanyl group

Arm Description

Subjects will receive oral Etoricoxib120 mg 30 minutes before fractional curettage then added intravenous Propofol 2 mg/kg when start the procedure

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

Outcomes

Primary Outcome Measures

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]
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]
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]

Secondary Outcome Measures

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
Amount of intravenous Propofol used in the procedure
Record dose of intravenous Propofol that used in TIVA
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

Full Information

First Posted
September 28, 2018
Last Updated
September 9, 2019
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03697733
Brief Title
Comparison Efficiency of Oral Etoricoxib Versus Intravenous Fentanyl on Post Operative Pain in Curettage Under TIVA
Official Title
Efficiency of Oral Etoricoxib Versus Intravenous Fentanyl On Post Operative Pain In Curettage Under TIVA : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Uterine Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Etoricoxib group
Arm Type
Experimental
Arm Description
Subjects will receive oral Etoricoxib120 mg 30 minutes before fractional curettage then added intravenous Propofol 2 mg/kg when start the procedure
Arm Title
Intravenous Fentanyl group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
fractional curettage
Intervention Description
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
Primary Outcome Measure Information:
Title
post operative pain
Description
Compare efficacy of oral Etoricoxib and intravenous Fentanyl for post fractional curettage pain by using a visual analog pain scale [Score 0-10]
Time Frame
at 60 minute after operation
Title
post operative pain
Description
Compare efficacy of oral Etoricoxib and intravenous Fentanyl for post fractional curettage pain by using a visual analog pain scale [Score 0-10]
Time Frame
at 30 minute after operation
Title
post operative pain
Description
Compare efficacy of oral Etoricoxib and intravenous Fentanyl for post fractional curettage pain by using a visual analog pain scale [Score 0-10]
Time Frame
at 15 minute after operation
Secondary Outcome Measure Information:
Title
Adverse effect from the drugs during and post operation
Description
Record subject experience of the following symptoms : nausea and vomiting ,dizziness, drowsiness ,allergic reaction ,chest pain ,and gastrointestinal bleeding or gastrointestinal discomfort
Time Frame
since subject receive drugs until 60 minutes after procedure
Title
Amount of intravenous Propofol used in the procedure
Description
Record dose of intravenous Propofol that used in TIVA
Time Frame
only intraoperative time
Title
The first time pain reliever was used in post operation
Description
Record the first time patient asked for post operative pain reliver or visual analog pain score > 5
Time Frame
within 60 minutes after the procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
apichaya buraputthananon
Organizational Affiliation
Rajavithi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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