Effects of premedication with intravenous ketamine and midazolam on success and complication rates of caudal anesthesia in neonates undergoing lower abdominal surgery
Infants are not able to express their pain or discomfort; moreover, they cannot work with PCA (Patient Controlled Analgesia)Pumps. Therefore, regional anesthesia techniques for controlling postsurgical pain in lower abdominal surgery are preferred .In the cases which anatomical or physiological changes increase the risk of general anesthesia, regional anesthesia methods are favored. Caudal anesthesia is a popular technic for lower abdominal surgeries below the umbilicus in children & infants. In order to decrease the chance of block failure caused unintentionally by movements during procedure, we decided to study the success & complication rates of caudal block with added intravenous premedication (midazolam and/or ketamine)
In a prospective randomized single blind clinical trial, we will study 90 infants with ASA (American Society of Anesthesiologists) classes 1&2 scheduled to undergo lower abdominal surgeries in a 12 month period Patients will be divided into 3 randomized groups.
1-(control group) caudal block with bupivacaine .
2-caudal block with bupivacaine plus intravenous midazolam 0.1mg/kg
2-caudal block with bupivacaine plus intravenous midazolam 0.1mg/kg & intravenous ketamine 0.3mg/kg
Absence of pain and lower limb paralysis 15 minutes after the block will be defined as is Successfulness of the block
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305164041N8
Registration date:2013-05-22, 1392/03/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-05-22, 1392/03/01
Registrant information
Name
Mahin Seyedhejazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 2252
Email address
seidhejazie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of premedication with intravenous ketamine and midazolam on success and complication rates of caudal anesthesia in neonates undergoing lower abdominal surgery
Public title
Effects of premedication withintravenous drugs on caudal block
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: neonate infants with ASA (American Society of Anesthesiologists) classes 1&2 scheduled to undergo lower abdominal surgeries in a 12 month period.
Exclusion critria: existens of pain and lower limb paralysis 15 minutes after the block will be defined as failure of the block and they will be excluded.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Approval date
2013-04-18, 1392/01/29
Ethics committee reference number
602/4/5
Health conditions studied
1
Description of health condition studied
Lower abdominal surgeries
ICD-10 code
K40.2
ICD-10 code description
Bilateral inguinal hernia, without obstruction or gangrene
Primary outcomes
1
Description
pain
Timepoint
Two, 4, 6 and 8 hours postoperative
Method of measurement
Neonatal infant pain scale(NIPS)
Secondary outcomes
empty
Intervention groups
1
Description
1-(control group) caudal block with bupivacaine
Category
Treatment - Drugs
2
Description
intervention group:caudal block with bupivacaine plus intravenous midazolam 0.1 mg/kg & intravenous ketamine 0.3mg/kg
Category
Treatment - Drugs
3
Description
intervention group:caudal block with bupivacaine plus intravenous midazolam 0.1mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz children Hospital
Full name of responsible person
Dr.Mahin Seyedhejazi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Alireza Ostadrahimi
Street address
Tabriz University of Medical Sciences-Golgasht Ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Tabriz Children Hospital
City
Tabriz
Postal code
Phone
+98 41 1477 3957
Fax
Email
seidhejazie@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Tabriz Children Hospital
City
Tabriz
Postal code
Phone
+98 41 1477 3957
Fax
Email
seidhejazie@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Tabriz Children Hospital
City
Tabriz
Postal code
Phone
+98 41 1477 3957
Fax
Email
seidhejazie@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)