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Tramadol Versus Lidocaine Infiltration for Tonsillectomy

Primary Purpose

Peri-tonsillar Analgesic Infiltration, Tonsillectomy, Postoperative Pain

Status

Completed

Phase

Phase 2

Locations

Saudi Arabia

Study Type

Interventional

Intervention

peritonsillar infiltration

About this trial

This is an interventional treatment trial for Peri-tonsillar Analgesic Infiltration focused on measuring Anaesthesia, tonsillectomy, inflammatory response, stress response, tramadol, lidocaine

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Dammam University KFHU
UD-KFHU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo

lidocaine

Tramadol

Arm 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.

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.

(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.

Outcomes

Primary Outcome Measures

inflammatory and stress response

CRP Acute phase protein

Secondary Outcome Measures

Hemodynamic changes

MBP HR

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.

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.

Full Information

NCT ID

NCT01552096

First Posted

March 5, 2012

Last Updated

March 15, 2014

Sponsor

Imam Abdulrahman Bin Faisal University

1. Study Identification

Unique Protocol Identification Number

NCT01552096

Brief Title

Tramadol Versus Lidocaine Infiltration for Tonsillectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Imam Abdulrahman Bin Faisal University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Anaesthesia, tonsillectomy, inflammatory response, stress response, tramadol, lidocaine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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.

Arm Title

lidocaine

Arm Type

Active Comparator

Arm 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.

Arm Title

Tramadol

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

peritonsillar infiltration

Other Intervention Name(s)

as in description

Intervention Description

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

Primary Outcome Measure Information:

Title

inflammatory and stress response

Description

CRP Acute phase protein

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Hemodynamic changes

Description

MBP HR

Time Frame

24 hours

Title

pain score

Description

VAS The time to first request for analgesia and the number of subjects receiving meperidine during the first 12 hours will be recorded.

Time Frame

24 hours

Title

Side-effects

Description

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

laila Telmesani, MD

Organizational Affiliation

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hany A. Mowafi, MD

Organizational Affiliation

Associate Professor

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Alaa M. Khidr, MD

Organizational Affiliation

Assistant Consultant

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Abdulhadi Al'Saflan, MD

Organizational Affiliation

Assistant Consultant

Official's Role

Study Chair

Facility Information:

Facility Name

Dammam University KFHU

City

Al-Khobar

State/Province

ZIP/Postal Code

31952

Country

Saudi Arabia

Facility Name

UD-KFHU

City

Al-Khobar

State/Province

ZIP/Postal Code

31952

Country

Saudi Arabia

12. IPD Sharing Statement

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Tramadol Versus Lidocaine Infiltration for Tonsillectomy

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