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Completed

NCT Number: NCT02387918

Prevention of POV After Paediatric Tonsillectomy

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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Key information

Conditions

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

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine Assuit University

Egypt, Assuit, 71111

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

acupuncture

Device

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

Primary outcomes

  1. Incidence of POV after tonsillectomy with or without adenoidectomy

    Time frame: 24 hours postoperatively

    by 3 point ordinal scale

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 13, 2015
Registry last updated
Jan 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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