Back to resultsPrevention of POV After Paediatric Tonsillectomy
Primary Purpose
Vomiting
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexamethasone
Acupuncture
Sponsored by
About this trial
This is an interventional prevention trial for Vomiting focused on measuring Tonsillectomy, postoperative vomiting (POV), Dexamethasone, Acupuncture
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine Assuit University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dexamethasone
Acupuncture
Arm Description
Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.
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
Outcomes
Primary Outcome Measures
Incidence of POV after tonsillectomy with or without adenoidectomy
by 3 point ordinal scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02387918
Brief Title
Prevention of POV After Paediatric Tonsillectomy
Official Title
Vomiting After Tonsillectomy in Children: A Comparison of Dexamethasone and Acupuncture
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting
Keywords
Tonsillectomy, postoperative vomiting (POV), Dexamethasone, Acupuncture
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture treatment (just after induction of anaesthesia and for approximately 20 minutes)
Primary Outcome Measure Information:
Title
Incidence of POV after tonsillectomy with or without adenoidectomy
Description
by 3 point ordinal scale
Time Frame
24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seham Ibrahim, Lecturer
Organizational Affiliation
health,Higher education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Assuit University
City
Egypt
State/Province
Assuit
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Prevention of POV After Paediatric Tonsillectomy
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