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Completed

NCT Number: NCT01552096

Tramadol Versus Lidocaine Infiltration for 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.

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Key information

Conditions

Peri-tonsillar Analgesic Infiltration Fractures, Bone Fractures, Stress Inflammatory Response Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Tonsillectomy Wounds and Injuries

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dammam University KFHU, Khobar, EP, Saudi Arabia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

peritonsillar infiltration

Drug

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

Other names: as in description

Primary outcomes

  1. inflammatory and stress response

    Time frame: 24 hours

    CRP Acute phase protein

Secondary outcomes

  1. Hemodynamic changes

    Time frame: 24 hours

    MBP HR

  2. pain score

    Time frame: 24 hours

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

  3. Side-effects

    Time frame: 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2012
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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