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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009639

Enrollment

Registered

2024-07-11

Start date

2024-06-17

Completion date

Unknown

Last updated

2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Experimental group(Maxigesic): 1 vial (100ml) of maxigesic by intravenous injection over 15 minutes. Control group(Paracetamol): 1000 mg/100 ml of paracetamol by intravenous injection over 15 m

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Opioid consumption for pain control after orthognathic surgery under general anesthesia between the experimental group and the comparison group	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Korea, Republic of

Contacts

Public ContactSeung-Hwa Ryoo

Seoul National University Dental Hospital

ryooes00@snu.ac.kr+82-2-6256-3290

Outcome results