Tramadol Versus Lidocaine Infiltration for Tonsillectomy

Phase 2

Completed

• Conditions: Peri-tonsillar Analgesic Infiltration; Tonsillectomy; Postoperative Pain; Inflammatory Response
• Interventions: Drug: peritonsillar infiltration

• Registration Number: NCT01552096
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-15
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	peritonsillar infiltration	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.
lidocaine	peritonsillar infiltration	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.
Tramadol	peritonsillar infiltration	(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.

Primary Outcome Measures

Name	Time	Method
inflammatory and stress response	24 hours	CRP Acute phase protein

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Dammam University KFHU; 🇸🇦 Al-Khobar, EP, Saudi Arabia

UD-KFHU; 🇸🇦 Al-Khobar, EP, Saudi Arabia