1.Finding best oral drop as premedication for pain control of intravenous cannulation , anxiety control and sedation
2.Comparison of side effects in both premedication(midazolam and ketamine or midazolam and pethidine in children
3.comparison of midazolam and ketamine with midazolam and pethidine in anxiety contorl of parent sepration
4.comparison of midazolam and ketamine with midazolam and pethidine in pain of intravenous cannulation
5.comparison of midazolam and ketamine with midazolam and pethidine for improving cooperation during intravenous cannulation
Design
After choosing cases they will be randomly divided in two groups.Each group contains 20 pediatric patient who is having plastic surgery. A written consent is obtained from parents for participation of child in the study.
The dorp is given to the paitents by a nurse who dose not know which drop is it. then the nurse will assess the effects of drop and write them in tabels.
Settings and conduct
The study is performed in operation room of hazrate fatemeh hospital.The study is double blinded. The data is written in tabels and will analayzed with SPSS .
Participants/Inclusion and exclusion criteria
inclusion cirteria: Pediatric patients between 1 to 5 years without any past medical history whom are admitted in operation room of hazrate fateme hospital.
exclusion criteria: having past medical history, recent upper respiratory infection ,GI obstruction ,ASA score more than 1, signs of ICP raising
Intervention groups
In this study we have to group of pediatric patients whom are having plastic surgery .First group is given oral drop of midazoalm and ketamine .The second group is having oral drop of midazoalm and pethidine .There will be a comparison between the oral drops in their effect and side effects before intravenous cannulation.
Main outcome variables
Pain score,anxiety, parent sepration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210306050591N1
Registration date:2021-12-20, 1400/09/29
Registration timing:registered_while_recruiting
Last update:2021-12-20, 1400/09/29
Update count:0
Registration date
2021-12-20, 1400/09/29
Registrant information
Name
Parham Nikniaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 6391
Email address
parhamnik@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-21, 1400/08/30
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of oral midazolam-ketamine and midazolam-pethidine as premidication in children who were admited for surgery in fatemeh hospital in 2021
Public title
A comparison of oral midazolam-ketamine and midazolam-pethidine as premidication in children who were admited for surgery in fatemeh hospital in 2021
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 1 to 5 year
without any past medical history
admitted for plastic surgery
Exclusion criteria:
past medical history
systemic diseases
recent upper airways diseases
gastrointestinal obstruction
having symptoms of high level of Icp
asa number more than 1
Age
From 1 year old to 5 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
for randomization we use block randomization method.we put patients in to groups and use sealedenvelope website for making sequence.in each block we have 4 cases. We use A for group whom are taking midazolam and ketamine and use B for the second group(pethidine and midazolam).At last we put cards with the blcoks written on them in envelopes. by this method allocation concealment is done.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person who give the drug to the children doesn't know the type of soluotion .The child who is taking the medicine doesn't know the tyep of medicene.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics commitee of Iran university of medical sciences
Street address
Iran university of medical sciences, Hemat hyw,Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-03-02, 1399/12/12
Ethics committee reference number
IR.IUMS.FMD.REC.1399.778
Health conditions studied
1
Description of health condition studied
pediatric anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain score
Timepoint
15 minuets after intervention
Method of measurement
pain score scale
2
Description
side effects
Timepoint
15 minutes after intervention
Method of measurement
visual
3
Description
agitation
Timepoint
15 minuets after intervention
Method of measurement
Richmond agitation sedation scale(RASS)
Secondary outcomes
empty
Intervention groups
1
Description
Oral ketamine and midazolam drop is given pediatric patients between 1 to 5 years whom are having plastic surgery .
Category
Treatment - Drugs
2
Description
Intervention group: Oral pethidine and midazolam drop is given pediatric patients between 1 to 5 years whom are having plastic surgery .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Fatemeh(S) Hospital
Full name of responsible person
Parham Nikniaee
Street address
Hazrate Fatemeh(S) Hospital, next to Shafagh park, 21st., Asad abadi st. , Yousef abad st. Tehran
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
crtfatima@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Keyvani
Street address
Iran university of medical science Shahid Hemmat highway Tehran Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?