Compare the Safety, Efficacy, and Opioid Consumption of Maxigesic and Paracetamol for Pain Control in the Recovery Room Following Maxillofacial Surgery
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0009639
- Lead Sponsor
- Seoul National University Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
? Patients aged 19 to 60 years old
? Patients who are American Society of Anesthesiologists physical status I or II
? Patients who are scheduled for double jaw surgery
? Patients with body mass index (BMI) between 18.5 and 30 kg/m2
? Patients with hypersensitivity or allergy to NSAIDs, opioids, acetaminophen
? Patients taking medications that may affect clinical trial results, such as pain relievers, sedatives, and psychiatric medications
? Patients who are pregnant or breastfeeding
? Patients with liver, kidney or brain dysfunction
? Contraindications to NSAIDs or paracetamol, such as previous gastric ulcer, heart failure, renal failure, thrombocytopenia, liver dysfunction, asthma, nasal polyps, hypersensitivity to the drug, and patients taking heavy alcohol.
? Patients for whom VAS evaluation is expected to be impossible
? Patient with pain before surgery
? Patients weighing less than 50 kg
? Other patients determined by the investigator to be excluded
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Opioid consumption for pain control after orthognathic surgery under general anesthesia between the experimental group and the comparison group
- Secondary Outcome Measures
Name Time Method visual analog scale(pain), observer assessment of alertness/sedation scale, blood pressure, pulse rate, oxygen saturation, additional analgesic dose and number of doses, nausea/vomiting occurrence(0=none, 1=nausea, 2=retching, 3=vomiting), presence or absence of shivering, total amount of analgesic administered through PCA, total number of bolus attempts and number of administrations, amount of rescue analgesics, adverse drug reactions, patient satisfaction; Demographic information, visual analog scale(pain);visual analog scale(pain), observer assessment of alertness/sedation scale, blood pressure, pulse oxygen saturation; blood pressure, pulse rate, pulse oxygen saturation, local anesthetics dose, opioids dose during surgery