Pain Pain
Conditions
Interventions
One oral tablet of 90-mg etoricoxib plus a scheduled tablet of 500-mg paracetamol every 6 hours for a maximum of 2,000 mg per day,One oral starch-filled placebo tablet plus a scheduled tablet of 500-m
Experimental Drug,Placebo Comparator Drug
Etoricoxib plus paracetamol,Placebo plus paracetamol
Sponsors
Research Center, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Pregnant women aged more than or equal to 18 years old 2. Pregnant women who are fluent in Thai language
Exclusion criteria
Exclusion criteria: 1. Pregnant women with a history of drug hypersensitivity to aspirin, NSAIDs, etoricoxib, paracetamol, sulfamethoxazole, mifepristone, or misoprostol 2. Pregnant women with history of cardiovascular disease, ischemic heart disease, congestive heart failure, hypertension, cerebrovascular disease, peripheral arterial disease, active peptic ulcer disease, renal disease, or liver disease 3. Pregnant women who do not achieve complete abortion within 24 hours after administration of misoprostol 4. Pregnant women who are candidate for surgical intervention for second-trimester abortion such as inevitable abortion with active bleeding with unstable vital signs 5. Pregnant women who decline to participate 6. Pregnant women who have received any prohibited medication within 24 hours prior to initiation of misoprostol such as ibuprofen, naproxen, diclofenac, ketorolac, aspirin, celecoxib, parecoxib, morphine, tramadol, pethidine, methadone, gabapentin, pregabalin, ketamine, benzodiazepine, and additional paracetamol dose beyond paracetamol 500 mg orally every 6 hours 7. Pregnant women who have received any prohibited treatment within 24 hours prior to initiation of misoprostol such as paracervical block, peripheral nerve block, and spinal block
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain score at expulsion Visual analog pain scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Average pain score during abortion Visual analog pain scale,Number of additional opioid use during abortion total dose,Satisfaction score after abortion 5-point Likert scale,Vital signs during abortion and at expulsion Temperature, heart rate, blood pressure, respiratory rate | — |
Countries
Thailand
Contacts
Public ContactWaranyu Lertrat
Department of Obstetrics and Gynecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Outcome results
None listed