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Comparison of the efficiency of oral Etoricoxib versus intravenous Fentanyl on post operative Pain in curettage under TIVA: A randomized controlled trial
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| apichaya buraputthananon | Department of Medical Services Ministry of Public Health of Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi Hospital | Bangkok | Bangkok | 10400 | Thailand |
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| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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|
| Amount of intravenous Propofol used in the procedure |
Record dose of intravenous Propofol that used in TIVA |
| only intraoperative time |
| 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 |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |