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

Abnormal Uterine Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697733
• Other study ID #: Etovsfen
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: October 2018
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Pain, Postoperative
• Uterine Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Amount of intravenous Propofol used in the procedure	Record dose of intravenous Propofol that used in TIVA	only intraoperative time
Secondary	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