Tramadol Versus Lidocaine Infiltration for Tonsillectomy

Phase 2CompletedNCT01552096

Imam Abdulrahman Bin Faisal University90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Peri-tonsillar Analgesic Infiltration Tonsillectomy Postoperative Pain Inflammatory Response

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (2)

Dammam University KFHU

Khobar, EP, Saudi Arabia

UD-KFHU

Khobar, EP, Saudi Arabia

Outcomes

Primary Outcomes

inflammatory and stress response

CRP Acute phase protein

Time frame: 24 hours

Secondary Outcomes

Hemodynamic changes

MBP HR

Time frame: 24 hours

pain score

VAS The time to first request for analgesia and the number of subjects receiving meperidine during the first 12 hours will be recorded.

Time frame: 24 hours

Side-effects

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.

Time frame: 24 hours