Post-tonsillectomy pain
Conditions
Interventions
Sufentanil Group:0.2 µg/kg sufentanil intravenously
Oxycodone Group:0.2 mg/kg Oxycodone intravenously
Sponsors
The Second Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 7 Years
Inclusion criteria
Inclusion criteria: 1. The legal guardian fully understands, voluntarily participates in this study, and signs the informed consent form; 2. Age 3~7 years old, gender is not limited; 3. Elective tonsillectomy or tonsillectomy with adenoidectomy under general anesthesia; 4. Subjects with American Society of Anesthesiologists (ASA) grade I or II. 5. Estimated operation time<=45min; 6. The weight is within the normal weight range of the corresponding age;
Exclusion criteria
Exclusion criteria: 1. Pediatric populations that require special care or need to be supervised by courts/social welfare institutions; 2. Opioid tolerance; 3. Subjects with significant liver and kidney dysfunction, ALT and/or AST>=1.5 times the upper limit of normal value; Subjects with total bilirubin >=1.5 times the upper limit of normal; Subjects with serum creatinine (Cr) >=1.5 times the upper limit of normal value; 4. Combined with severe cardiovascular system diseases; 5. Severe obstructive sleep apnea; 6. Subjects with mental system diseases and cognitive dysfunction; 7. Received the following drugs before randomization: other drugs used within 5 half-lives before randomization (if the half-life is unclear, the first 7 days of randomization shall prevail) and affect the analgesic effect judged by the investigator (subject to the actual drug instructions), including but not limited to NSAIDs, monoamine oxidase inhibitors, glucocorticoids (except nebulized inhalation), sedative drugs, antiepileptic drugs, antidepressants, anticonvulsants, anxiolytic drugs, etc.; 8. History of surgery that interferes with the safety and efficacy evaluation of the study as assessed by the investigator before randomization, and/or plans to undergo other surgical procedures at the same time; 9. Children who have participated in clinical trials of other drugs (received trial drugs) within 3 months before the screening period; 10. Other situations judged by the investigator to be unsuitable for participating in this clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the pain intensity-time curve during the first 4 hours postoperatively (AUC0-4); | — |
Secondary
| Measure | Time frame |
|---|---|
| All spontaneously reported and directly observed AEs and SAEs;Hospitalization duration;Intraoperative remifentanil dosage;Length of stay in PACU;Area under the pain intensity-time curve (AUC0-6>, AUC0-2) at different postoperative time intervals;Extubation time (time from discontinuation of anesthetics to tracheal extubation);Postoperative non-opioid analgesic administration frequency and dosage;Postoperative rescue sufentanil analgesia rate in PACU (Post-Anesthesia Care Unit) and rescue sufentanil dose (µg/kg);Propofol rescue rate in PACU;Incidence of emergence agitation; | — |
Countries
China
Contacts
Public ContactYuan Kaiming;Li Jun
The Second Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed