Chronic tonsillitis/Tonsillar hypertrophy
Conditions
Interventions
Control Group:Paracetamol 15 mg/kg/dose as needed (PRN)
Intervention Group A (Ibuprofen Monotherapy):Scheduled ibuprofen 10 mg/kg every 6 hours (q6h)
Paracetamol 15 mg/kg/dose PRN
Intervention Group B (Ropivacaine + Ibuprofen):Peritonsillar infiltration of 0.2% ropivacaine (0.1 ml/kg) intraoperatively
Scheduled ibuprofen 10 mg/kg q6h
Paracetamol 15 mg/kg/dose PRN
Intervention Group C (Dexamethasone + Ibuprofen):Intravenous dexamethasone sodium phosphate 0.2 mg/kg once daily (QD)(from surgery day to postoperative 24 hours)
Scheduled ibuprofen 10 mg/kg q6h
Parac
Intervention Group D (Multimodal Protocol):Peritonsillar infiltration of 0.2% ropivacaine (0.1 ml/kg) intraoperatively
Intravenous dexamethasone sodium phosphate 0.2 mg/kg QD
(from surgery day to post
Sponsors
Hebei Eye Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Age range: Children aged 3-12 years undergoing elective extracapsular tonsillectomy (with or without adenoidectomy) 2. Clear surgical indications: Meeting criteria per Technical Specifications for Coblation Tonsillectomy and Adenoidectomy in Children 3. Legally authorized representative provides written informed consent 4. Possesses cognitive capacity to participate in standardized pain assessment
Exclusion criteria
Exclusion criteria: 1.Patients undergoing intracapsular tonsillectomy 2.History of chronic pain conditions or long-term analgesic use 3.Contraindications or documented hypersensitivity to any protocol-specified analgesics 4.Concomitant severe neurological disorders or cognitive impairment 5.Requirement for concurrent surgical procedures (e.g., tympanostomy) 6.Anticipated poor adherence: Inability of child/parent to complete pain assessments, medication logs, or protocol requirements 7.Investigator-determined contraindications: Other conditions deemed to compromise safety or validity per investigator assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Face,Legs,Activity,Crying,Consolability(FLACC);faces pain scale-Revised(FPS-R);Partens postoperative pain measure(PPPM); | — |
Secondary
| Measure | Time frame |
|---|---|
| operative time;Frequency of use of painkillers;Probability of complication occurrence; | — |
Countries
China
Contacts
Public ContactZhitao Fan
Hebei Eye Hospital
Outcome results
None listed