Tramadol Versus Lidocaine Infiltration for Tonsillectomy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Peri-tonsillar Analgesic Infiltration Tonsillectomy Postoperative Pain Inflammatory Response	Drug: peritonsillar infiltration	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Comparative Study of the Effects of Pre-incisional Infiltration of Tramadol or Lidocaine on the Inflammatory Response After Tonsillectomy.

Resource links provided by NLM:

MedlinePlus related topics: Tonsils and Adenoids

Drug Information available for: Lidocaine hydrochloride Lidocaine Tramadol

U.S. FDA Resources

Further study details as provided by Dammam University:

Primary Outcome Measures:

inflammatory and stress response [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
CRP Acute phase protein

Secondary Outcome Measures:

Hemodynamic changes [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
MBP HR
pain score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
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 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	90
Study Start Date:	December 2011
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: as in description

Eligibility

Ages Eligible for Study:	2 Years to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552096

Contacts

Contact: Mohamed Tahan, MD

89666666 ext 2022

mohamedrefaateltahan@yahoo.com

Locations

Saudi Arabia
Dammam University KFHU	Active, not recruiting
Al-Khobar, EP, Saudi Arabia, 31952
UD-KFHU	Recruiting
Al-Khobar, EP, Saudi Arabia, 31952
Contact: Mohamed R Tahan, MD 89666666 ext 2021 mohamedrefaateltahan@yahoo.com

Sponsors and Collaborators

Dammam 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

More Information

No publications provided

Responsible Party:	Dammam University
ClinicalTrials.gov Identifier:	NCT01552096 History of Changes
Other Study ID Numbers:	#2012082
Study First Received:	March 5, 2012
Last Updated:	December 30, 2012
Health Authority:	Saudi Arabia: Ministry for Higher Education

Keywords provided by Dammam University:

Anaesthesia
tonsillectomy
inflammatory response

stress response
tramadol
lidocaine

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Lidocaine
Tramadol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Narcotics
Analgesics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 22, 2013