Tramadol Versus Lidocaine Infiltration for Tonsillectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-11-30

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.

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Detailed Description

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Conditions

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Peri-tonsillar Analgesic Infiltration Tonsillectomy Postoperative Pain Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

peritonsillar infiltration

Intervention Type DRUG

1.5 ml around each tonsil, 3 minutes before surgical incision as per group description

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.

Group Type ACTIVE_COMPARATOR

peritonsillar infiltration

Intervention Type DRUG

1.5 ml around each tonsil, 3 minutes before surgical incision as per group description

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.

Group Type EXPERIMENTAL

peritonsillar infiltration

Intervention Type DRUG

1.5 ml around each tonsil, 3 minutes before surgical incision as per group description

Interventions

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peritonsillar infiltration

1.5 ml around each tonsil, 3 minutes before surgical incision as per group description

Intervention Type DRUG

Other Intervention Names

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as in description

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No