Prevention of POV After Paediatric Tonsillectomy

January 20, 2016 updated by: Seham Mohamed Moeen Ibrahim, Assiut University

Vomiting After Tonsillectomy in Children: A Comparison of Dexamethasone and Acupuncture

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Assuit
      • Egypt, Assuit, Egypt, 71111
        • faculty of medicine assuit university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone
Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.
Drug: Dexamethasone
Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.
Active Comparator: 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
Device: Acupuncture
Acupuncture treatment (just after induction of anaesthesia and for approximately 20 minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of POV after tonsillectomy with or without adenoidectomy
Time Frame: 24 hours postoperatively
by 3 point ordinal scale
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Seham Ibrahim, Lecturer, health,Higher education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 13, 2015

Study Record Updates

Last Update Posted (Estimate)

January 22, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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