Tramadol Versus Lidocaine Infiltration for Tonsillectomy

Imam Abdulrahman Bin Faisal University

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain; Inflammatory Response; Tonsillectomy; Peri-tonsillar Analgesic Infiltration

Treatments: Drug: peritonsillar infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT01552096

#2012082

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

90 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: peritonsillar infiltration

lidocaine

Active Comparator group

Description:

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.

Treatment:

Drug: peritonsillar infiltration

Tramadol

Experimental group

Description:

(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.

Treatment:

Drug: peritonsillar infiltration