Tramadol Versus Lidocaine Infiltration for Tonsillectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dammam University
ClinicalTrials.gov Identifier:
NCT01552096
First received: March 5, 2012
Last updated: March 15, 2014
Last verified: March 2014
  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:


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.


Enrollment: 90
Study Start Date: December 2011
Study Completion Date: November 2013
Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Saudi Arabia
Dammam University KFHU
Al-Khobar, EP, Saudi Arabia, 31952
UD-KFHU
Al-Khobar, EP, Saudi Arabia, 31952
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: March 15, 2014
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
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Lidocaine
Tramadol
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 20, 2014