Prevention of POV After Paediatric Tonsillectomy

Phase 4

Completed

• Conditions: Vomiting
• Interventions: Device: Acupuncture; Drug: Dexamethasone

• Registration Number: NCT02387918
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-13
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	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
Dexamethasone	Dexamethasone	Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.

Primary Outcome Measures

Name	Time	Method
Incidence of POV after tonsillectomy with or without adenoidectomy	24 hours postoperatively	by 3 point ordinal scale

Trial Locations

Locations (1)

Faculty of Medicine Assuit University; 🇪🇬 Egypt, Assuit, Egypt