In a double-blind and , 60 children aged between 6 and 16 years candidate for elective herniorrhaphy during 2014–2015 enrolled the study. Patients were randomly divided into two groups. The first group, received 5 ml/kg of 12.5% CHO solution two hours before surgery, and the second group received similar volumes of plain water. After admission to the operating room, surgery is performed under general anesthesia. After the completion of surgery patients were transferred to the recovery room. Patients were kept in the recovery room for two hours and then moved to the ward. Patients received acetaminophen suppositories every 4 hours (10 mg/kg) for analgesia. Postoperative pain was measured 2, 6, 12 and 24 after the surgery using Visual Analog Scale (VAS).If the pain score was more than four, the patient received 1 mg/kg of intramuscular pethidine. The frequency of PONV and pain; 2, 6, 12 and 24 hours after the surgery as well as opioid consumption were recorded. Thirst and hunger (not at all=0, a little=2, moderately=4 and very much=6) at the time of admission to the operating room as well as the first request of food or water were recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710318433N5
Registration date:2017-11-08, 1396/08/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-08, 1396/08/17
Registrant information
Name
Mohammad Reza Fazel
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
fazel_mr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University Of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral carbohydrate on pain, postoperative nausea and vomiting in Children
Public title
Effect of oral carbohydrate on pain, postoperative nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age 6-16 years old ;elective unilateral herniorrhaphy; Exclusion Criteria: history of diabetes; autoimmune disease; use of non-steroidal analgesics drugs
Age
From 6 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Vice Chancellor for Research & Technology, Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Blvd, 5th Km
City
Kashan
Postal code
8715988141
Approval date
2013-01-07, 1391/10/18
Ethics committee reference number
9167
Health conditions studied
1
Description of health condition studied
Acute pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
pain
Timepoint
2-6-12-24 hours
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
nausea and vomiting
Timepoint
2-6-12-24 hours
Method of measurement
Number of cases occurred
Intervention groups
1
Description
In the intervention group, patients received 5 ml/kg of 12.5% CHO solution two hours before surgery.
Category
Treatment - Drugs
2
Description
In the control group, patients received 5 ml/kg of plain water two hours before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid beheshti hospital
Full name of responsible person
Mohammad Reza Fazel
Street address
shahid beheshti hospital, Ghotbe Ravandi Blvd, 5th Km
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research & Technology, Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi (Ph.D)
Street address
Ghotbe Ravandi Blvd, 5th Km
City
Kashan
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 & Technology, Kashan University of Medical Sciences
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
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Reza Fazel
Position
Anesthesiologist
Other areas of specialty/work
Street address
shahid beheshti hospital, Ghotbe Ravandi Blvd, 5th Km
City
Kashan
Postal code
Phone
+98 31 5554 0026
Fax
Email
fazel_mr@kaums.ac.ir, drmfazel@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Reza Fazel
Position
Anesthesiologist
Other areas of specialty/work
Street address
shahid beheshti hospital, Ghotbe Ravandi Blvd, 5th Km
City
Kashan
Postal code
Phone
+98 31 5554 0026
Fax
Email
fazel_mr@kaums.ac.ir, drmfazel@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Reza Fazel
Position
Anesthesiologist
Other areas of specialty/work
Street address
shahid beheshti hospital, Ghotbe Ravandi Blvd, 5th Km
City
Kashan
Postal code
Phone
+98 31 5554 0026
Fax
Email
fazel_mr@kaums.ac.ir, drmfazel@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)