The purpose of this study was comparision effect of gabapentin and sup of acetaminophen in control of postoperative pain and nausea and vomiting.the main inclusion criteria included all children 7-15 years old candidate for adenotonsilectomy surgery and with recurrent and chronic tonsilitis , and exclusion criteria incluced history of seizure and gabapantin usage and taking pain killers in last 24 hours. the patients divided in to 30 member groups. In first groups childs recived 10/mg/kg, gabapentin 2 hour before anesthesia and second group recived acetaminophen after maintenance of anesthesia. Both groups anesthetized in same manner then before induction of anesthesia and in 2,4,6,12,24 hour after operation both group were studied for existence of nausea and vomiting ,types of drugs used ,their dosage and degree of pain. Outside following time intervals if patients were complaining for pain or nausea and vomiting they were treated according to protocol. Paitents were monitored for vital signs and respiratory after operation , and in case of hypotension there were treated by ephedrine and in case of respiratiory depression they received oxygen by ambobag and ventilation .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102115963N7
Registration date:2017-02-01, 1395/11/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-01, 1395/11/13
Registrant information
Name
Soudabeh Haddadi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13332383068
Email address
so_haddadi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2016-10-31, 1395/08/10
Expected recruitment end date
2017-08-01, 1396/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of gabapentin and acetapinophen susspention on postoperative pain after adenotonsilcetomy
Public title
A survey comparing effect of gabapentin and acetaminophen suspention on postoperative pain after tonsil removal surgery in children reciveing these drugs
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :
7-15 year old child candidate for adenotonsilectomy; Recurrent tonsillitis; chronic tonsillitis; Obstructive sleep apnea; Breathing with open mouth; Snoring and dysphagia
Exclusion criteria :
Known allergy to gabapentin and acetaminophen ; History of sezuire and gabapentin usage; Renal or hepatic dysfunction; Usage of analgesic in last 24 hours; Opiod addiction; Known G6PD deficiency; Diarrhea and dehydration; Bleeding abnormality; operation lasting more then 90 min
Age
From 7 years old to 15 years old
Gender
Both
Phase
3
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Science
Street address
Vice-Chancellor for Research Building, Opposite of SepahBank,ShahidBeheshti Blvd, Rasht
City
Rasht
Postal code
Approval date
2016-08-13, 1395/05/23
Ethics committee reference number
IR.GUMS.REC.1395.157
Health conditions studied
1
Description of health condition studied
Acute tonsillitis
ICD-10 code
J03
ICD-10 code description
Acute tonsillitis
Primary outcomes
1
Description
Postoperative pain
Timepoint
2,4,6,12,24 hour after surgery
Method of measurement
Visual analog score
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
2,4,6,12,24 hour after operation
Method of measurement
Based on asking patients in time intervals
Intervention groups
1
Description
Control group: recived acetaminophen after maintenance of anesthesia. Both groups anesthetized in same manner
Category
Treatment - Drugs
2
Description
Interventional group: recieved gabapentin 10mg/kg 2 hour before anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Sudabeh Haddadi
Street address
Amiralmomenin Hospital, 17 Shahrivar St
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Science, Vice Chancellor for Research
Full name of responsible person
Susan Komaee
Street address
Vice-Chancellor for Research Building, Opposite of SepahBank,ShahidBeheshti Blvd, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Science, Vice Chancellor for Research
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
Guilan University of Medical Sciences
Full name of responsible person
Dr SoudabehHaddadi
Position
Professor
Other areas of specialty/work
Street address
Amiralmomenin Hospital, 17 Shahrivar St
City
Rasht
Postal code
Phone
+98 13 3322 5242
Fax
Email
So_haddadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Soudabeh Haddadi
Position
Professor
Other areas of specialty/work
Street address
Amiralmomenin Hospital, 17 Shahrivar St
City
Rasht
Postal code
Phone
+98 13 3322 5242
Fax
Email
So_haddadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Soudabeh Haddadi
Position
Professor
Other areas of specialty/work
Street address
Amiralmomenin Hospital, 17 Shahrivar St
City
Rasht
Postal code
Phone
+98 13 3322 5242
Fax
Email
So_haddadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)