Comparison of rehydration and ketamine on postoperative pain in children undergoing adenotonsillectomy in shahid Mohammadi hospital of Bandar Abbas at 2014
Aim of this study: Comparing the effects of fluid administration with intravenous ketamin on postoperative pain after adenotonsillectomy in children.
Type of study: Randomized, double blind clinical trial.
Population of study: Eighty infants who are candidate for adenotonsillectomy operation in Shahid Mohammadi Hospital
Inclusion criteria: age 5 - 8 years; ASA I-II
Exclusion criteria: Systemic disease; Metabolic disease; Endocrine disease; mental retardation; failure to thrive; history of allergic disease; tonsilar abscess; hypertension; chronic pain; individuals who are on treatment for chronic pain
Method: After informing the parents about the investigation and obtaining consent the infants will be allocated randomly (drawing random cards method) into either group ketamine (K) or fluid therapy (NS). Five minutes before anesthesia induction for group K intravenous ketamine (0.2 mg/kg) and for group NS normal saline (10 cc/kg) will be administered. Induction of anesthesia is provided by fentanyl (2 microgm/kg), lidocaine (1 mg/kg) and sodium thiopental (5 mg/kg) which are followed by tracheal intubation. Anesthesia maintenance will be by oxygen and nitrous oxide (50/50%) with propofol infusion (100 microgram/kg/min). The patients will be evaluated during their recovery by the visual analogue scale (0 – 100 points) at 0, 2, 6, 12 and 24 hours after the end of operation. The level of sedation will be assessed by Ramsey-H scoring system (1-6 points). The data will be collected by a student who is unaware of the type of drug applied during the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071318091N3
Registration date:2016-04-14, 1395/01/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-14, 1395/01/26
Registrant information
Name
Fekrat Fereydoon
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 4009
Email address
fereydoon.fekrat@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
governmental resources of Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of rehydration and ketamine on postoperative pain in children undergoing adenotonsillectomy in shahid Mohammadi hospital of Bandar Abbas at 2014
Public title
comparing the effects of fluid therapy and ketamin drug administration on pain after adeniod and tonsilar
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 5 - 8 years; ASA I-II
Exclusion criteria: Systemic disease; Metabolic disease; Endocrine disease; mental retardation; failure to thrive; history of allergic disease; tonsilar abscess; hypertension; chronic pain; individuals who are on treatment for chronic pain
Age
From 5 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Deputy for Research, and Medical Ethics Committee of Hormozgan University of Medical Sciences
Street address
Joomhoori Islami Blvd., Shahid Mohammadi Hospital
City
Bandar Abbas
Postal code
7919915519
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
HUMS.REC.1394.63
Health conditions studied
1
Description of health condition studied
Hypertrophy of tonsils with hypertrophy of adenoids disease
ICD-10 code
J35.3
ICD-10 code description
Hypertrophy of tonsils with hypertrophy of adenoids
Primary outcomes
1
Description
to decrease the pain level after tonsilectomy
Timepoint
after the end of tonsilectomy
Method of measurement
Visual Analogue Scale: VAS
Secondary outcomes
1
Description
nausea and vomiting
Timepoint
In recovery at 0, 2, 6, 12, 24 hours after adenotonsilectomy operation
Method of measurement
Descriptional
2
Description
Sedation condition
Timepoint
In recovery at 0, 2, 6, 12, 24 hours after adenotonsilectomy operation
Method of measurement
Ramsey-H score
Intervention groups
1
Description
Five minutes before anesthesia induction for group K intravenous ketamine (0.2 mg/kg) will be administered. Induction of anesthesia is provided by fentanyl (2 microgm/kg), lidocaine (1 mg/kg) and sodium thiopental (5 mg/kg) which are followed by tracheal intubation. Anesthesia maintenance will be by oxygen and nitrous oxide (50/50%) with propofol infusion (100 microgram/kg/min).
Category
Treatment - Drugs
2
Description
Five minutes before anesthesia induction for group NS normal saline (10cc/kg) will be administered. Induction of anesthesia is provided by fentanyl (2 microgm/kg), lidocaine (1 mg/kg) and sodium thiopental (5 mg/kg) which are followed by tracheal intubation. Anesthesia maintenance will be by oxygen and nitrous oxide (50/50%) with propofol infusion (100 microgram/kg/min).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Alireza Abdolahzade Baghaee
Street address
Joomhoori Islami Blv., Shahid Mohammadi Hospital
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Abdulazim Nejatizadeh
Street address
Joomhoori Islami Blv., Deputy of Research Center, Shahid Mohammadi Hospita
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan 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
Shahid Mohammadi Hospital
Full name of responsible person
Alireza Abdolahzade Baghaee
Position
Assisstant Professor of Anesthesiology and Intensive care - Fellowship of pain
Other areas of specialty/work
Street address
Joomhoori Islami Blv., Deputy of Research Center, Shahid Mohammadi Hospital
City
Bandar Abbas
Postal code
7919915519
Phone
+98 76 3334 5009
Fax
Email
bagha_ar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Alireza Abdolahzade Baghaee
Position
Assisstant Professor of Anesthesiology and Intensive care - Fellowship of Pain
Other areas of specialty/work
Street address
oomhoori Islami Blv., Deputy of Research Center, Shahid Mohammadi Hospital
City
Bandar Abbas
Postal code
Phone
+98 76 3334 5009
Fax
Email
bagha_ar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Fereydoon Fekrat
Position
Specialist in Anesthesiology and Intensive care
Other areas of specialty/work
Street address
Joomhoori Islami Blv., Shahid Mohammadi Hospital
City
Bandar Abbas
Postal code
7919915519
Phone
+98 76 3334 5009
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)