Comparison of the effect of fentanyl on the incidence of cough in surgery with general anesthesia in children with or without previous injection of midazolam
Comparison of the effect of fentanyl on the incidence of cough in surgery with general anesthesia in children with or without previous injection of midazolam
Design
Clinical trial with a control group, with parallel groups, phase 3, on 118 patients in two groups of 59 people, without blinding, not randomized
Settings and conduct
Children aged 4 to 12 years undergoing surgery with general anesthesia referred to Bo Ali Hospital in Tehran in 1403. For the experimental group, 0.05 mg/kg of the child's weight of midazolam was used before the injection of fentanyl (about 1-1/5 cc) and for the control group, the same volume of normal saline serum was used at the rate of 0.5 mg/kg of the child's weight and then fentanyl was used. will be. Then, the occurrence or non-occurrence of cough after the operation, the type of cough, the child's breathing rate per minute, the oxygen saturation level of the arterial blood are evaluated and recorded in the data collection form. It should be noted that narcotics are injected under the same conditions for patients and are performed under cardiac, blood pressure and pulse oximetry monitoring.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children aged 4 to 12 who are candidates for surgery with general anesthesia
Consent to participate in the study
Exclusion criteria:
Children with a history of drug allergy
Intervention groups
For the experimental group, 0.05 mg/kg of the child's weight midazolam was used before the injection of fentanyl (about 1-1/5 cc) and for the control group, the same volume of normal saline serum was used at the rate of 0.5 mg/kg of the child's weight and then fentanyl was used. will be.
Main outcome variables
Cough
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240707062357N1
Registration date:2024-08-03, 1403/05/13
Registration timing:prospective
Last update:2024-08-03, 1403/05/13
Update count:0
Registration date
2024-08-03, 1403/05/13
Registrant information
Name
Parmida Latifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3307 1538
Email address
parmidalatifi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of fentanyl on the incidence of cough in surgery with general anesthesia in children with or without previous injection of midazolam
Public title
Comparison of the effect of fentanyl on the incidence of cough in surgery with general anesthesia in children with or without previous injection of midazolam
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children from 4 to 12 years are candidates for surgery with general anesthesia
Consent to participate in the study
Exclusion criteria:
Children with a history of drug allergy
Age
From 4 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
118
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Islamic Azad University of Medical Sciences
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences. Amir Pabarja St., Amir Pabarja St., Doktor Shariati St., Gol Ikh St. corner
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2024-06-22, 1403/04/02
Ethics committee reference number
IR.IAU.TMU.REC.1403.167
Health conditions studied
1
Description of health condition studied
Pediatric surgery
ICD-10 code
Z98.8
ICD-10 code description
Other specified postsurgical states
Primary outcomes
1
Description
Cough
Timepoint
6 hours after the operation
Method of measurement
Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the test group, 0.05 mg/kg of the child's weight of midazolam is used before the injection of fentanyl (about 1-1.5 cc).
Category
Prevention
2
Description
Control group: For the control group, normal saline serum with the same volume at the rate of 0.5 mg/kg of the child's weight and then fentanyl will be used.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bo Ali Hospital, Tehran
Full name of responsible person
Parmida Latifi
Street address
Damavand St, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
booali.hospital96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Parsania
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences. Corner of Gol Ikh St., Ayane Blvd., Amir Pabarja St., Qolhek Road, Doktor Shariati St.
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Parmidalatifi@Gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Parmida Latifi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences. Amir Pabarja St., Amir Pabarja St., Doktor Shariati St., Gol Ikh St. corner
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Parmidalatifi@Gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Parmida Latifi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences. Amir Pabarja St., Amir Pabarja St., Doktor Shariati St., Gol Ikh St. corner
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Parmidalatifi@Gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Parmida Latifi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters building of Tehran Islamic Azad University of Medical Sciences. Amir Pabarja St., Amir Pabarja St., Doktor Shariati St., Gol Ikh St. corner
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Parmidalatifi@Gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD