Study of Effect of preoperative oral clonidine on nausea and vomiting after appendectomy surgery in children aged between 3-12 years in Bahrami hospital
The aim of this trial is to assess the effect of preoperative oral Clonidine on the incidence of vomiting after appendectomy in children. After signing written informed consent by parents, 60 children, aged 3-12 years, with no contraindication for using study drugs, and scheduled for appendectomy, will be enrolled in this double- blind randomized controlled trial and randomly allocated into two groups. Patients with any history of anti emetic or opioids consumption, during the 24 hours before surgery, or those who need to receive different anesthetic regimen will be excluded. The patients in the intervention group will receive Clonidine, 4µg/kg orally in 20 ml apple juice while in the control group will receive only 20 ml apple juice one hour before anesthesia induction. The anesthetic regimen is similar for both groups. Incidence of vomiting, times of anti emetic drug administration in first 24 hours after surgery, and hemodynamic parameters will be recorded and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011225225N1
Registration date:2010-12-24, 1389/10/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-12-24, 1389/10/03
Registrant information
Name
Seyed mohammad Mireskandari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 8931
Email address
mireskandari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2011-03-01, 1389/12/10
Expected recruitment end date
2011-06-20, 1390/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Effect of preoperative oral clonidine on nausea and vomiting after appendectomy surgery in children aged between 3-12 years in Bahrami hospital
Public title
Study of Effect of preoperative oral clonidine on nausea and vomiting after appendectomy surgery in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: informed consent of parents, no contraindication for using study drugs, age 3 to 12 year old, scheduled for appendectomy, no history of motion sickness, digestive disorders, or other diseases related to nausea and vomiting, ASA class I & II
Exclusion criteria: any history of drugs for nausea and vomiting and opioids during the 24 hours before surgery, need for a different anesthetic regimen, time limitation for delivering study drugs before surgery
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Bahrami Children Hospital, Shaheed Kiaee St, Damavand Ave, Tehran
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
20083
Health conditions studied
1
Description of health condition studied
Appendicitis
ICD-10 code
K35.9
ICD-10 code description
Primary outcomes
1
Description
Nausea
Timepoint
frequency during the first 24 hours after surgery
Method of measurement
history taking from patient or parents or nurses
2
Description
Vomiting
Timepoint
frequency during the first 24 hours after surgery
Method of measurement
history taking from patient or parents or nurses
3
Description
Need for anti nausea and vomiting drug
Timepoint
frequency of nasea and vomiting during the first 24 hours after surgery
Method of measurement
information taken from patient's records
Secondary outcomes
1
Description
Systolic and diastolic blood pressure
Timepoint
every 10 minutes during surgery and every 2 hours postoperatively
Method of measurement
mannometer
2
Description
heart rate
Timepoint
continuously during surgery and every 2 hours postoperatively
Method of measurement
calculation of pulse rate
Intervention groups
1
Description
Intervention group: Clonidine, 4µg/kg orally in 20 ml apple juice, one hour before anesthesia induction
Category
Treatment - Drugs
2
Description
Control group: 20 ml apple juice, one hour before anesthesia induction
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahrami hospital
Full name of responsible person
Dr Seyed Mohammad Mireskandari
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr Seyed Mohammad Mireskandari
Street address
Bahrami Children Hospital, Shaheed Kiaee St, Damavand Ave, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences and Health Services
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr Seyed Mohammad Mireskandari
Position
Assistant professor of anesthesia department
Other areas of specialty/work
Street address
Bahrami Children Hospital, Shaheed Kiaee St, Damavand Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2386
Fax
Email
mireskandari@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)