Dexamethasone Versus Local Infiltration Technique for Tonsillectomy in Children

NCT02355678 | Completed

• 1 other identifier: 201212
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nausea and vomiting

  incidence of early PONV in the post-anesthesia care unit (PACU) and late PONV on the floor and 5 days after discharge

  5 postoperative days

Secondary Outcomes (1)

• Postoperative pain

  5 postoperative days

Study Arms (2)

IV Dex

EXPERIMENTAL

dexamethasone 0.5 mg/kg IV with placebo pre-incision infiltration

Drug: dexamethasone; Drug: General anesthesia; Procedure: Tonsillectomy; Procedure: gastric content suction; Drug: Tramadol hydrochloride; Drug: Propacetamol hydrochloride; Drug: Paracetamol Suppository

Infiltration

EXPERIMENTAL

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; Drug: General anesthesia; Procedure: Tonsillectomy; Procedure: gastric content suction; Drug: Tramadol hydrochloride; Drug: Propacetamol hydrochloride; Drug: Paracetamol Suppository

Interventions

dexamethasone DRUG

IV 0.5 mg/kg

IV Dex

Local anesthetic infiltration DRUG

Using 25 G-3.5 cm curved needle

Infiltration

General anesthesia DRUG

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%.

IV Dex; Infiltration

Tonsillectomy PROCEDURE

Mono-polar electrocautery or cold dissection

IV Dex; Infiltration

gastric content suction PROCEDURE

By orogastric tube

IV Dex; Infiltration

Tramadol hydrochloride DRUG

If Visual Analogue Scale was greater than 5

IV Dex; Infiltration

Propacetamol hydrochloride DRUG

If Visual Analogue Scale was between 4 and 5

IV Dex; Infiltration

Paracetamol Suppository DRUG

If Visual Analogue Scale was less than 4

IV Dex; Infiltration

Eligibility Criteria

• Age: 2 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients scheduled for total or partial tonsillectomy with or without adenoidectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

Related Publications (1)

• Naja Z, Kanawati S, Al Khatib R, Ziade F, Naja ZZ, Naja AS, Rajab M. The effect of IV dexamethasone versus local anesthetic infiltration technique in postoperative nausea and vomiting after tonsillectomy in children: A randomized double-blind clinical trial. Int J Pediatr Otorhinolaryngol. 2017 Jan;92:21-26. doi: 10.1016/j.ijporl.2016.10.030. Epub 2016 Oct 28.

  PMID: 28012528 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Anesthesia, General; Tonsillectomy; Tramadol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anesthesia; Anesthesia and Analgesia; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairperson of Anesthesia and Pain Management Department

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 4, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 21, 2015

Record last verified: 2015-08

Locations

LE (1)