Tramadol Versus Lidocaine Infiltration for Tonsillectomy

Study Overview
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Brief Summary
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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.

Official Title
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A Comparative Study of the Effects of Pre-incisional Infiltration of Tramadol or Lidocaine on the Inflammatory Response After Tonsillectomy.

Conditions
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Peri-tonsillar Analgesic Infiltration, Tonsillectomy, Postoperative Pain, Inflammatory Response

Intervention / Treatment
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* Drug: peritonsillar infiltration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The placebo group (n=30) will receive a submucosal infiltration with 3 mL of normal saline (1.5 ml around each tonsil), 3 minutes before surgical incision. | Drug: peritonsillar infiltration<br>* 1.5 ml around each tonsil, 3 minutes before surgical incision as per group description<br>* Other names: as in description;|
| Active Comparator: lidocaine<br>will receive a total of 2 mg.kg-1 of 2% lidocaine HCl (Xylocaine, Astra-Zeneca,) in 3 mL of normal saline (1.5 ml around each tonsil), 5 minutes before surgical incision. | Drug: peritonsillar infiltration<br>* 1.5 ml around each tonsil, 3 minutes before surgical incision as per group description<br>* Other names: as in description;|
| Experimental: Tramadol<br>(n=30) will receive a submucosal infiltration with 2 mg kg-1 tramadol in 3 mL of normal saline (1.5 ml around each tonsil), 3 minutes before surgical incision. | Drug: peritonsillar infiltration<br>* 1.5 ml around each tonsil, 3 minutes before surgical incision as per group description<br>* Other names: as in description;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory and stress response | CRP Acute phase protein | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic changes | MBP HR | 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. | 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. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anaesthesia, tonsillectomy, inflammatory response, stress response, tramadol, lidocaine