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Compare the Safety, Efficacy, and Opioid Consumption of Maxigesic and Paracetamol for Pain Control in the Recovery Room Following Maxillofacial Surgery

Not Applicable
Recruiting
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
Inclusion Criteria

? 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

Exclusion Criteria

? 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
NameTimeMethod
Opioid consumption for pain control after orthognathic surgery under general anesthesia between the experimental group and the comparison group
Secondary Outcome Measures
NameTimeMethod
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
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