Tramadol Versus Lidocaine Infiltration for Tonsillectomy

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

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 Overview

• Status: Completed
• Conditions: Postoperative Pain; Inflammatory Response; Tonsillectomy; Peri-tonsillar Analgesic Infiltration
• Intervention / Treatment: Drug: peritonsillar infiltration

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Saudi Arabia
  • EP
    • Al-Khobar, EP, Saudi Arabia, 31952
      • Dammam University KFHU
    • Al-Khobar, EP, Saudi Arabia, 31952
      • UD-KFHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; 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; 1.5 ml around each tonsil, 3 minutes before surgical incision as per group description; Other Names: as in description
ACTIVE_COMPARATOR: lidocaine; 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; 1.5 ml around each tonsil, 3 minutes before surgical incision as per group description; Other Names: as in description
EXPERIMENTAL: Tramadol; (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; 1.5 ml around each tonsil, 3 minutes before surgical incision as per group description; Other Names: as in description

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Imam Abdulrahman Bin Faisal University
• Investigators: Principal Investigator: laila Telmesani, MD, UD; Study Chair: Hany A. Mowafi, MD, Associate professor; Study Chair: Alaa M. Khidr, MD, Assistant Consultant; Study Chair: Abdulhadi Al'Saflan, MD, Assistant Consultant

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: March 5, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (ESTIMATE): March 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 18, 2014
• Last Update Submitted That Met QC Criteria: March 15, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: lidocaine; stress response; Anaesthesia; tonsillectomy; tramadol; inflammatory response
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: #2012082