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

NCT03697733 | Completed DMC

• 1 other identifier: Etovsfen
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abnormal Uterine Bleeding

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Adverse effect from the drugs during and post operation

  since subject receive drugs until 60 minutes after procedure

• Amount of intravenous Propofol used in the procedure

  only intraoperative time

• The first time pain reliever was used in post operation

  within 60 minutes after the procedure

Study Arms (2)

Oral Etoricoxib group

EXPERIMENTAL

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

Intravenous Fentanyl group

PLACEBO COMPARATOR

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

Interventions

fractional curettage PROCEDURE

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

Intravenous Fentanyl group; Oral Etoricoxib group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who having abnormal uterine bleeding undergoing fractional curettage under TIVA

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• apichaya buraputthananon

  Department of Medical Services Ministry of Public Health of Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 5, 2018
• Study Start: November 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: May 1, 2019
• Last Updated: December 3, 2024

Record last verified: 2018-10

Locations

TH (1)