The aim of the study: Comparison of the effect of Plasil, Ondansetron, and Dexamethasone on nausea and vomiting in Children candidate for tonsillectomy. Study design: After explaining the purpose of the study and obtaining the informed consent, patients will be allocated into A, B and C groups.Randomization will be performed using random block sizes of 3. The study is single-center, single blind and phase 3 trial and patients and physician will be blind about the type of injection drug. Inclusion criteria: Children from 6 to 12 years old candidate for tonsillectomy. Exclusion criteria: Coagulopathy; congenital heart disease; drug allergies; anatomical anomalies; obstruction of respiratory airway. Sample size: 120 patients will participate in the study with 40 patients in each group. Interventions: Plasil 0.1-0.2 mg/kg IM, ondansetron 0.15 mg/kg/dose IV, Dexamethasone 0.5 mg/kg IV. Primary outcomes: nausea and vomiting
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060834386N1
Registration date:2017-09-16, 1396/06/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-16, 1396/06/25
Registrant information
Name
Negar Hamidi
Name of organization / entity
Islamic Azad University of Shahrood
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 4530
Email address
n-hamidi@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Islamic Azad University of Shahrood
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Plasil, Ondansetron, and Dexamethasone on nausea and vomiting in Children candidate for tonsillectomy
Public title
The effect of Plasil, Ondansetron, and Dexamethasone on nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children from 6 to 12 years old candidate for tonsillectomy Exclusion criteria: Coagulopathy; congenital heart disease; drug allergies; anatomical anomalies; obstruction of respiratory airway.
Age
From 6 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Shahrood
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
Shahrood
Postal code
3613773955
Approval date
2017-05-16, 1396/02/26
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1396.1
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
J35.3
ICD-10 code description
Hypertrophy of tonsils with hypertrophy of adenoids
Primary outcomes
1
Description
Nausea
Timepoint
every hours, until 6 hours after surgery
Method of measurement
Observation
2
Description
Vomiting
Timepoint
every hours, until 6 hours after surgery
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: Plasil 0.1-0.2 mg/kg IM
Category
Treatment - Drugs
2
Description
Intervention 2: Ondansetron 0.15 mg/kg/dose IV
Category
Treatment - Drugs
3
Description
Intervention 3: Dexamethasone 0.5 mg/kg IV
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
khatam Alanbia Hospital of Shahrood
Full name of responsible person
Yousef Kolukhi
Street address
khatam Alanbia Hospital, Tehran Blvd, Shahrood
City
Shahrood
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
Full name of responsible person
Sahebali Manafi
Street address
Islamic Azad University of Shahroud, Tehran Blvd
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
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
Islamic Azad University of Shahrood
Full name of responsible person
Negar Hamidi
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd, Shahrood
City
Shahroud
Postal code
Phone
+98 23 3239 6714
Fax
Email
negar_hamidi@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Shahrood
Full name of responsible person
Yousef Kolukhi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
shahrood
Postal code
Phone
+98 23 3239 4661
Fax
Email
dr.yousefkolookhianesthesia@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Shahroud
Full name of responsible person
Negar Hamidi
Position
Medical student
Other areas of specialty/work
Street address
Tehran Blvd, Shahrood Islamic Azad University, Shahroud
City
Shahrood
Postal code
Phone
+98 23 3223 1249
Fax
Email
n-hamidi@iau-shahrood.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)