Tramadol Versus Lidocaine Infiltration for Tonsillectomy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552096
• Other study ID #: #2012082
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2012
• Last updated: March 15, 2014
• Start date: December 2011
• Est. completion date: November 2013

Study information

• Verified date: March 2014
• Source: Dammam University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry for Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• peritonsillar infiltration
1.5 ml around each tonsil, 3 minutes before surgical incision as per group description

Locations

Country	Name	City	State
Saudi Arabia	Dammam University KFHU	Al-Khobar	EP
Saudi Arabia	UD-KFHU	Al-Khobar	EP

Sponsors (1)

Lead Sponsor	Collaborator
Dammam University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory and stress response	CRP Acute phase protein	24 hours	No
Secondary	Hemodynamic changes	MBP HR	24 hours	Yes
Secondary	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	No
Secondary	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	Yes