Prevention of POV After Paediatric Tonsillectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-10-31

Brief Summary

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Tonsillectomy is one of the most frequently performed surgical procedures in children. It remains associated with a high morbidity related to postoperative vomiting (POV), pain, risk of bleeding, and dehydration due to impaired oral intake. Current medications for POV have limited efficacy and may even be associated with potential side-effects. Non-pharmacological techniques such as acupuncture has been investigated as alternatives to antiemetics and as additional treatment modalities for POV.

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Detailed Description

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Postoperative vomiting (POV) is one of the most common complication in children undergoing tonsillectomy. Its incidence is between 62% and 73% when no prophylactic antiemetic is given. Because of Limited efficacy and side effects with antiemetics, many alternative treatment had been used. Acupuncture is simple, inexpensive, and noninvasive with minimal side effects. The objective of this study is to compare two prophylactic antiemetic treatments :

* Dexamethasone (0.15 mg/kg) immediately after induction of anaesthesia
* Acupuncture treatment (immediately after induction of anaesthesia and for approximately 20 minutes)

Conditions

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Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone

Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.

Acupuncture

Acupuncture at point Neiguan (Pericardium-6) bilaterally and at point CV13 (Shang Wen) with acupuncture needles (0.25x25 mm) to a depth of approximately 7 mm will be performed on the children immediately after induction of anaesthesia and removed after 20 minutes

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type DEVICE

Acupuncture treatment (just after induction of anaesthesia and for approximately 20 minutes)

Interventions

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Dexamethasone

Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.

Intervention Type DRUG

Acupuncture

Acupuncture treatment (just after induction of anaesthesia and for approximately 20 minutes)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* children aged 2-8 y.
* children ASA 1-2
* tonsillectomy with or without adenoidectomy

Exclusion Criteria

* American Society of Anesthesiologists grade greater than or equal to III (patient with severe systemic disease)
* intravenous induction
* contraindication to steroids
* Rash or local infection over an acupuncture point
* administration of steroids in the 24 hours before the surgery
* Use of medication with antiemetic effect within the 24 hours before surgery
* Gastric or intestinal diseases
* refusal of parents

Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No