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Dexamethasone Versus Local Infiltration Technique for Tonsillectomy in Children

NCT02355678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2015-08-21

No results posted yet for this study

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

Interventions

DRUG

dexamethasone

IV 0.5 mg/kg

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

Sponsors & Collaborators

  • Makassed General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Lebanon

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02355678 on ClinicalTrials.gov