Inflammatory Response, Peri-tonsillar Analgesic Infiltration, Postoperative Pain, Tonsillectomy
Conditions
Keywords
Anaesthesia, tonsillectomy, inflammatory response, stress response, tramadol, lidocaine
Brief summary
The investigators postulate that the use of pre-incisional peritonsillar infiltration of tramadol or lidocaine reduces both the inflammatory response and postoperative analgesic consumption, without harmful effects. Therefore, the present study is designed to evaluate the effects of infiltration of tramadol or lidocaine on the postoperative acute-phase serum protein, C-reactive protein, and analgesic consumption after tonsillectomy.
Interventions
DRUGperitonsillar infiltration
1.5 ml around each tonsil, 3 minutes before surgical incision as per group description
Sponsors
Imam Abdulrahman Bin Faisal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* ASA I & II preschool children aged 2-6 years, undergoing elective tonsillectomy with or without adenoidectomy, under general anaesthesia. Indications for tonsillectomy will be chronic recurrent tonsillitis or tonsillar hypertrophy
Exclusion criteria
* Patients with a history of allergy to tramadol or amide local anaesthetics, epilepsy, or taking cardiovascular, antihypertensive, steroids, or anti-inflammatory medications, those with cardiac, liver, or kidney diseases, or any underlying systemic diseases or acute infectious processes will be excluded from the study. All operations will be performed, using an electro-dissection technique, by the same surgeon.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| inflammatory and stress response | 24 hours | CRP Acute phase protein |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic changes | 24 hours | MBP HR |
| pain score | 24 hours | VAS The time to first request for analgesia and the number of subjects receiving meperidine during the first 12 hours will be recorded. |
| Side-effects | 24 hours | postoperative stridor, laryngospasm, cyanosis, bleeding, seizures, sedation (four-point verbal rating scores (VRS): awake, drowsy, rousable or deep sleep); nausea and vomiting (0: no nausea; 1: nausea no vomiting; 2: nausea and vomiting), respiratory depression (ventilatory frequency 10), and desaturation (92%), at 0, 1, 2, 4, 6, 8, and 12 h after surgery. |
Countries
Saudi Arabia
Outcome results
None listed