Effect of gabapentin on the prevention of emergence agitation in children after general anesthesia
Design
Double-blind randomized clinical trial
Settings and conduct
Intervention group: 15 mg / kg of gabapentin is dissolved in 10 cc of water and given to the children in the case group one hour before entering the operating room.
Control group: Water (placebo) is given to the control group with equal volume of case group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Children under the age of twelve
Children candidates for tonsillectomy
Exclusion Criteria: History of heart, liver, kidney, mental diseases
Contraindications to the use of gabapentin
History of seizures
Intervention groups
Intervention group: 15 mg / kg of gabapentin is dissolved in 10 cc of water and given to the children in the case group one hour before entering the operating room.
Control group: Water (placebo) is given to the control group with equal volume of case group.
Main outcome variables
Agitation, Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N111
Registration date:2021-02-17, 1399/11/29
Registration timing:prospective
Last update:2021-02-17, 1399/11/29
Update count:0
Registration date
2021-02-17, 1399/11/29
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-27, 1399/12/09
Expected recruitment end date
2021-05-11, 1400/02/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of gabapentin on the prevention of emergence agitation in children after general anesthesia
Public title
Effect of gabapentin on the prevention of emergence agitation in children after general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children under the age of twelve
Children candidates for tonsillectomy
Exclusion criteria:
History of heart, liver, kidney, mental diseases
Contraindications to the use of gabapentin
History of seizures
Age
To 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed for the two intervention and control groups by using 4, 6 and 8 permutation blocks extracted from the site www.sealedenvelope.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
One hour before entering the operating room, 15 mg / kg of gabapentin is dissolved in 10 cc of water and given to the children of the case group and given to the control group (placebo) in equal volume.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2016-09-28, 1395/07/07
Ethics committee reference number
IR.SUMS.MED.REC.1395.s101
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
J03.00
ICD-10 code description
Acute streptococcal tonsillitis, unspecified
Primary outcomes
1
Description
Agitation
Timepoint
Time intervals 0,5,15,30,45,60 minutes after entering the recovery
Method of measurement
Watcha Scale
2
Description
Pain
Timepoint
Time intervals 0,5,15,30,45,60 minutes after entering the recovery
Method of measurement
Wong-baker faces Scale
Secondary outcomes
1
Description
Heart Rate
Timepoint
Time intervals 0,5,15,30,45,60 minutes after entering the recovery
Method of measurement
Monitoring
Intervention groups
1
Description
Intervention group: 15 mg / kg of gabapentin is dissolved in 10 cc of water and given to the children in the case group one hour before entering the operating room.
Category
Prevention
2
Description
Control group: Water (placebo) is given to the control group with equal volume of case group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Sayed Khademi
Street address
Khalili St, Khalili Educational and Medical Center
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3629 1470
Email
khalili@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaieanzadeh
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
vcrd@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Saied Khademi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
saied.khademi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Saied Khademi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street