Objective: Investigation of the effect of pain relief and sedation midazolam/ketamine with propofol/fentanyl during needle biopsy of kidney in children. This study is a clinical trial. Seventeen patients referring to Dr. Sheikh Hospital, were randomly allocated to two treatment groups and no blinding is done. The criteria for inclusion are, patients undergoing renal biopsy and between the age of 3 to 16 years old. Exclusion criteria are, prohibition from the use of ketamine, the use of narcotic analgesics, drug allergy and unwillingness for participation in the experiment. The first group and the second group will be tested with midazolam/ketamine and propofol/fentanyl respectively. Results of the study will be: degree of pain in patients based on SAS criteria, degree of patients’ calmness, degree of itching after 1, 3 and 6 hours after biopsy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610247892N5
Registration date:2017-03-11, 1395/12/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-11, 1395/12/21
Registrant information
Name
Anoosh Azarfar
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 51 1606 1227
Email address
azarfara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pain relief and sedation midazolam, ketamine with propofol during needle biopsy of kidney in childhood
Public title
Pain relief and sedation effect of midazolam/ketamine and propofol during needle biopsy of kidney in childhood
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: candidate renal biopsy; aged 16.3 years
Exclusion criteria: to prohibit the use of ketamine (a history of schizophrenia-surgical complications in the chip-history of problems and heart failure, glaucoma, history of lung disease such as severe asthma); of painkillers such as opioids; history of drug sensitivity; unwillingness to participate in the 5-under anesthesia in the operating room where the biopsy done.
Age
From 3 years old to 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
17
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 Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Postal code
99191-91778
Approval date
2015-01-09, 1393/10/19
Ethics committee reference number
911040
Health conditions studied
1
Description of health condition studied
Effect of pain relief and sedation
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease, unspecified
Primary outcomes
1
Description
The degree of pain-relieving itching -level of patient comfort
Timepoint
One houe-3 hour- 6 hour after biopsy
Method of measurement
Scoring face pain assessment
Secondary outcomes
1
Description
Itching
Timepoint
1 hour-3 hour--6hour
Method of measurement
Face evaluation
Intervention groups
1
Description
Intervention group: received propofol/fentanyl in doses of 0.5 to 1 mg per kg body weight.
Category
Treatment - Drugs
2
Description
Control group: midazolam/ketamine at doses of 30 to 50 micrograms and 0.25 to 1 mg per kg body weight.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Sheikh Hospital
Full name of responsible person
Street address
Dr. Sheikh Hospital, Tohid Squre, Motahari Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Yalda Ravanshad
Position
Community Medicine
Other areas of specialty/work
Street address
Clinical Research Development Unit, Quam Hospital, Ahmad Abad Avenue
City
Mashhad
Postal code
Phone
+98 915 301 7977
Fax
Email
ravanshady@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Anoosh Azarfar
Position
Associted proffesor
Other areas of specialty/work
Street address
Dr. Sheikh Hospital, Tohid Square, Motahari Avenue
City
Mashhad
Postal code
Phone
+98 51 3726 9021
Fax
Email
azarfara@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nayere Toosi
Position
Pediatrics residents
Other areas of specialty/work
Street address
169 number, Toofigh 15, Shahid Sadeghi street 10.
City
Mashhad
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)