Clinical trial NCT03697733: 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
Overall status: COMPLETED
Phase: NA
Conditions: Abnormal Uterine Bleeding
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2018-10-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: post operative pain
timeFrame: at 60 minute after operation
measure: post operative pain
timeFrame: at 30 minute after operation
measure: post operative pain
timeFrame: at 15 minute after operation
Secondary outcomes:
measure: Adverse effect from the drugs during and post operation
timeFrame: since subject receive drugs until 60 minutes after procedure
measure: Amount of intravenous Propofol used in the procedure
timeFrame: only intraoperative time
measure: The first time pain reliever was used in post operation
timeFrame: within 60 minutes after the procedure
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: apichaya buraputthananon
role: PRINCIPAL_INVESTIGATOR
References: