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“Effect of supplemental oxygen on post-tonsillectomy nausea and vomiting

Protocol summary

Summary
Objective:nausea and vomiting are one of the most common complications after tonsillectomy,with or without adenoidectomy in pediatric population.administration of supplemental oxygen 80% during surgery, has been shown to affect on reducing the incidence of postoperative nausea and vomiting. The purpose of this study was to test the efficacy of supplemental oxygen 80% during tonsillectomy on postoperative nausea and vomiting. Material and methods:One hundred two children scheduled for tonsillectomy,with or without adenoidectomy(Exclusion criteria were: diabetes mellitus or kidney disease,immune deficiency, gastroesophageal reflux disease, metabolic disorders,anemia, antiemetic therapy and craniofacial abnormality) under general anesthesia, randomly assigned to two groups: group1:administration of oxygen 30% and group2:administration of oxygen 80%.incidence of postoperative nausea and vomiting assessed and compared in 0-2, 2-6 and 6-24 hours after surgery in two groups. Results:incidence of post tonsillectomy nausea and vomiting in group 1 was: 13/72% in first 2 hours , 1/96% in 2-6hours and 1/96% in 6-24 hours after surgery and in group 2 was: 3/92%% in first 2 hours , 0 in 2-6hours and 1/96% in 6-24 hours after surgery. Conclusion:We found administration of supplemental oxygen 80% did not have statistically difference in post tonsillectomy nausea and vomiting between two groups(p=0/08 but it had beneficial effect in reducing postoperative nausea and vomiting in first 2 hours after surery in group2.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201012122893N3
Registration date: 2014-06-02, 1393/03/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-06-02, 1393/03/12
Registrant information
Name
Poopak Izadi
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 9437
Email address
izadi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University
Expected recruitment start date
2013-05-01, 1392/02/11
Expected recruitment end date
2013-10-01, 1392/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
“Effect of supplemental oxygen on post-tonsillectomy nausea and vomiting
Public title
“Effect of supplemental oxygen on post-tonsillectomy nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:all children 5-15 years old scheduled for tonsillectomy; Exclusion criteria were: comorbidities had an influence on postoperative nausea and vomiting such as diabetes mellitus or kidney disease,immune deficiency, gastroesophageal reflux disease, metabolic disorders,anemia, antiemetic therapy and craniofacial abnormality.
Age
From 5 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics in medical research committee
Street address
Shahed University
City
Tehran
Postal code
Approval date
2013-10-05, 1392/07/13
Ethics committee reference number
41/181320

Health conditions studied

1

Description of health condition studied
tonsillectomy candidates
ICD-10 code
J35.3
ICD-10 code description
Hypertrophy of tonsils with hypertrophy of adenoids

Primary outcomes

1

Description
nausea and vomiting
Timepoint
first 24 hours after surgery
Method of measurement
observation and assessment with statistical methods

Secondary outcomes

empty

Intervention groups

1

Description
group1:routine oxygen administration oxygen 30% with balanced nitrogen oxide70% all the time of anesthesia from induction till recovery. Group2:supplemental oxygen administration 80% all the time of anesthesia.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini Hospital
Full name of responsible person
Poopak Izadi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Poopak Izadi
Street address
Shahid Mostafa Khomeini Hospital,Italia Ave.,Keshavarz Blvd.,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Poopak Izadi
Position
Otolaryngologist
Other areas of specialty/work
Street address
Shahid Mostafa Khomeini Hospital,Italia Ave.,Keshavarz Blvd.,Tehran
City
Tehran
Postal code
Phone
+98 21 8896 9437
Fax
Email
izadi@shahed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Poopak Izadi
Full name of responsible person
Poopak Izadi
Position
otolaryngologist
Other areas of specialty/work
Street address
Shahid Mostafa Khomeini Hospital,Italia Ave.,Keshavarz Blvd.,Tehran
City
Tehran
Postal code
Phone
+98 21 8896 9437
Fax
Email
izadi@shahed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Poopak Izadi
Position
assistant professor
Other areas of specialty/work
Street address
Shahid Mostafa Khomeini Hospital,Italia Ave.,Keshavarz Blvd.,Tehran
City
Tehran
Postal code
Phone
+98 21 8896 9437
Fax
Email
izadi@shahed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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