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

March 5, 2012
March 15, 2014
December 2011
October 2013   (final data collection date for primary outcome measure)
inflammatory and stress response [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
CRP Acute phase protein
Same as current
Complete list of historical versions of study NCT01552096 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Tramadol Versus Lidocaine Infiltration for Tonsillectomy
A Comparative Study of the Effects of Pre-incisional Infiltration of Tramadol or Lidocaine on the Inflammatory Response After Tonsillectomy.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Peri-tonsillar Analgesic Infiltration
  • Tonsillectomy
  • Postoperative Pain
  • Inflammatory Response
Drug: peritonsillar infiltration
1.5 ml around each tonsil, 3 minutes before surgical incision as per group description
Other Name: as in description
  • 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.
    Intervention: Drug: peritonsillar infiltration
  • 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.
    Intervention: Drug: peritonsillar infiltration
  • 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.
    Intervention: Drug: peritonsillar infiltration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
November 2013
October 2013   (final data collection date for primary outcome measure)

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.
Both
2 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Saudi Arabia
 
NCT01552096
#2012082
Yes
Dammam University
Dammam University
Not Provided
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
Dammam University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP