Prevention of POV After Paediatric Tonsillectomy

Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02387918
• Other study ID #: SM2015
• Status: Completed
• Phase: Phase 4
• First received: February 27, 2015
• Last updated: January 20, 2016
• Start date: February 2015
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 8 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vomiting

Intervention

Drug:
• Dexamethasone
Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Assuit University	Egypt	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of POV after tonsillectomy with or without adenoidectomy	by 3 point ordinal scale	24 hours postoperatively	Yes