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CompletedNCT03697733Updated Dec 3, 2024

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

An interventional study of fractional curettage in Abnormal Uterine Bleeding, sponsored by Department of Medical Services Ministry of Public Health of Thailand. Completed at 1 site in Thailand. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by Department of Medical Services Ministry of Public Health of Thailand · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the 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

02

Conditions studied

  • Abnormal Uterine Bleeding

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03

In context

Metrorrhagia

103 studies on the registry are indexed under Metrorrhagia; 27 are open to participants now.

This study's enrollment of 60 is below the median of 109 across 79 interventional studies indexed under Metrorrhagia.

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Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand is the lead sponsor of 39 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Procedurefractional 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

06

What researchers measure

Primary outcomes

  1. post operative pain

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

    Time frame: at 60 minute after operation

  2. post operative pain

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

    Time frame: at 30 minute after operation

  3. post operative pain

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

    Time frame: at 15 minute after operation

Secondary outcomes

  1. 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

    Time frame: since subject receive drugs until 60 minutes after procedure

  2. Amount of intravenous Propofol used in the procedure

    Record dose of intravenous Propofol that used in TIVA

    Time frame: only intraoperative time

  3. 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

    Time frame: within 60 minutes after the procedure

07

Study locations

1 site
  • Rajavithi Hospital
    Bangkok, Bangkok 10400, Thailand
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2018 to primary completion in Apr 2019, 5 months.

Of 27 interventional studies with no phase under Metrorrhagia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 20. This study's 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 28, 2018
First posted
Oct 5, 2018
StartActual
Nov 1, 2018
Primary completionActual
Apr 1, 2019
CompletionActual
May 1, 2019
Last update
Dec 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03697733
Lead sponsor
Department of Medical Services Ministry of Public Health of Thailand
Responsible party
Sponsor
First posted
Oct 5, 2018
Start date
Nov 1, 2018
Primary completion
Apr 1, 2019
Completion
May 1, 2019
Last update
Dec 3, 2024

Study contacts

apichaya buraputthananon
principal investigator · Department of Medical Services Ministry of Public Health of Thailand

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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