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Dexamethasone Versus Local Infiltration Technique for Tonsillectomy in Children

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ClinicalTrials.gov Identifier: NCT02355678
Recruitment Status : Completed
First Posted : February 4, 2015
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Zoher Naja, Makassed General Hospital

Brief Summary:
Tonsillectomy is one of the most frequent surgical operations performed in children [1-4]. It is usually associated with postoperative nausea and vomiting (PONV) with an incidence ranging from 23% to 73% [2]. Dexamethasone has been shown to be effective in reducing PONV after tonsillectomy using standardized anesthetic technique [2, 5-7]. Previous studies utilizing a different technique, the pre-incision infiltration of local anesthesia, had shown to decrease post-tonsillectomy pain, reduce analgesic consumption and provide a rapid return to normal activity [8, 9]. Given the effectiveness of dexamethasone and the pre-incision infiltration anesthetic technique, it would be beneficial to compare the effect of each on PONV.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: dexamethasone Drug: Local anesthetic infiltration Drug: General anesthesia Procedure: Tonsillectomy Procedure: gastric content suction Drug: Tramadol hydrochloride Drug: Propacetamol hydrochloride Drug: Paracetamol Suppository Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Dexamethasone Versus Local Infiltration Technique on Postoperative Nausea and Vomiting After Tonsillectomy in Children: A Randomized Double-blind Clinical Trial
Study Start Date : January 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

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Arm Intervention/treatment
Experimental: IV Dex
dexamethasone 0.5 mg/kg IV with placebo pre-incision infiltration
Drug: dexamethasone
IV 0.5 mg/kg

Drug: General anesthesia

Induction by intravenous fentanyl (1.5 µg kg-1) and propofol (2.5 mg kg-1) followed by endotracheal intubation facilitated by atracurium (0.5 mg kg-1).

Maintenance with sevoflurane 1-3%, fentanyl (1-2 µg kg-1), nitrous oxide 70% and oxygen 30%.


Procedure: Tonsillectomy
Mono-polar electrocautery or cold dissection

Procedure: gastric content suction
By orogastric tube

Drug: Tramadol hydrochloride
If Visual Analogue Scale was greater than 5

Drug: Propacetamol hydrochloride
If Visual Analogue Scale was between 4 and 5

Drug: Paracetamol Suppository
If Visual Analogue Scale was less than 4

Experimental: Infiltration
The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 1.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 3 ml lidocaine 2%, 3 ml lidocaine 2% with epinephrine 1/200 000, 3 ml of bupivacaine 0.5%, 0.5 ml fentanyl 50 µg ml-1, and 0.3 ml clonidine 150 µg ml-1
Drug: Local anesthetic infiltration
Using 25 G-3.5 cm curved needle

Drug: General anesthesia

Induction by intravenous fentanyl (1.5 µg kg-1) and propofol (2.5 mg kg-1) followed by endotracheal intubation facilitated by atracurium (0.5 mg kg-1).

Maintenance with sevoflurane 1-3%, fentanyl (1-2 µg kg-1), nitrous oxide 70% and oxygen 30%.


Procedure: Tonsillectomy
Mono-polar electrocautery or cold dissection

Procedure: gastric content suction
By orogastric tube

Drug: Tramadol hydrochloride
If Visual Analogue Scale was greater than 5

Drug: Propacetamol hydrochloride
If Visual Analogue Scale was between 4 and 5

Drug: Paracetamol Suppository
If Visual Analogue Scale was less than 4




Primary Outcome Measures :
  1. Incidence of postoperative nausea and vomiting [ Time Frame: 5 postoperative days ]
    incidence of early PONV in the post-anesthesia care unit (PACU) and late PONV on the floor and 5 days after discharge


Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: 5 postoperative days ]


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Ages Eligible for Study:   2 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients scheduled for total or partial tonsillectomy with or without adenoidectomy

Exclusion Criteria:

Patients who received antiemetics, steroids, antihistaminics, or psychoactive drugs within 24 hours before surgery.

Patients who are suspected to have malignant neoplasm and signs of acute pharyngeal infection..

Patients who have asthma, diabetes mellitus, bleeding problems, and allergy towards bupivacaine.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355678


Locations
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Lebanon
Makassed General Hospital
Beirut, Lebanon
Sponsors and Collaborators
Makassed General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zoher Naja, Chairperson of Anesthesia and Pain Management Department, Makassed General Hospital
ClinicalTrials.gov Identifier: NCT02355678     History of Changes
Other Study ID Numbers: 201212
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone
Dexamethasone acetate
Propacetamol
Tramadol
Anesthetics
Anesthetics, Local
BB 1101
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid