Protocol summary

Summary
Objective: Control of postoperative pain is very important especially in pediatric patients and poor pain control leads to several complications such as different organs dysfunction and behavioral problems. We compared the analgesic effect of suppository acetaminophen, infiltration of marcaine in incisional site and caudal block with marcaine on postoperative pain in inguinal herniorrhaphy in children Methods: In this randomized, controlled clinical trial study, 90 children between the ages of 3 month to 7 years, ASA I-II, scheduled for elective unilateral inguinal heniorrhaphy were assigned to three equal groups. For postoperative analgesia, patients in the first group received suppository acetaminophen 20mg/kg, in the second group 2mg/kg marcaine 0.5% was infiltrated in the incisional site and in the third group caudal block was performed with 0.75 ml/kg marcaine. Premedication, induction and maintenance of anesthesia were the same in these three groups. For comparison of the effect of these three methods, initially FLACC(F=Face , L=Leg , A=Activity, C=Crying, C=Consolability)pain scale was evaluated 30 minutes after operation in the recovery room. Then FLACC pain scale was measured every one hour during the next 6 hours of postoperative period. The data were transferred to the SPSS-10 software and analyzed statistically with chi-square and analysis of variance test . P-Value less than 0.05 was considered meaningful. Primary outcome measure :analgesia Primary outcome time point:30minutes after operation in the recovery room and the next six hours with one hour interval Primary outcome method of measurement:FLACC scale

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110027695N1
Registration date: 2011-10-18, 1390/07/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-10-18, 1390/07/26
Registrant information
Name
Seyedeh Masoumeh Hosseini Valami
Name of organization / entity
Qazvin University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1334 8419
Email address
smhosseiniv@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice- chancellor for research ,Qazvin, university of medical sciences
Expected recruitment start date
2007-12-22, 1386/10/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the Effects of Suppository Acetaminophen, Local Marcaine Infiltration and Caudal Block with Marcaine on Postoperative Pain in Pediatric Inguinal Herniorrhaphy
Public title
The Comparison of the Effects of Suppository Acetaminophen, Local Marcaine Infiltration and Caudal Block with Marcaine on Postoperative Pain in Pediatric Inguinal Herniorrhaphy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : the ages of 3 month to 7 years, ASA I-II, scheduled for elective unilateral inguinal heniorrhaphy were assigned to three equal groups exclusion criteria :Patients with positive history of consumption of sedative;anxiolytic; opioids; corticostetroids and anticonvulsive drugs had been excluded from the study.
Age
To 7 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
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
Ethics committee of Qazvin university of medical sciense
Street address
Shahid Bahonar Blv, Qazvin City
City
Qazvin
Postal code
Approval date
2007-03-11, 1385/12/20
Ethics committee reference number
28/20/596

Health conditions studied

1

Description of health condition studied
Hernia
ICD-10 code
K40.3
ICD-10 code description
Unilateral or unspecified inguinal hernia, with obstruction, without gangrene

Primary outcomes

1

Description
analgesia
Timepoint
30 minutes after operation in the recovery room and the next six hours with one hour interval
Method of measurement
scale FLACC

Secondary outcomes

empty

Intervention groups

1

Description
Intervention1: Suppository acetaminophen 20mg/kg
Category
Treatment - Drugs

2

Description
Intervention2: 2mg/kg marcaine 0.5% was infiltrated in the incisional site
Category
Treatment - Drugs

3

Description
Intervention3: Caudal block was performed with 0.75 ml/kg marcaine(0.25% )
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Qods Hospital
Full name of responsible person
Dr Seyedeh Masomeh Hosseini Valami
Street address
Qods square, Qods Hospital , Qazvin City
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice-chancellor for research ,Qazvin university of medical sciences
Full name of responsible person
Dr Saeed Asefzadeh
Street address
Shahid Bahonar, Qazvin City
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice-chancellor for research ,Qazvin 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
Qazvin, University of Medical Sciences
Full name of responsible person
Dr Seyedeh Masomeh Hosseini Valami
Position
Assistant Professor/Anesthesia
Other areas of specialty/work
Street address
Shahid Bahonar Blv, Qazvin City
City
Qazvin
Postal code
Phone
+98 28 1333 4810
Fax
Email
smhosseiniv@qums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin, University of Medical Sciences
Full name of responsible person
Dr Seyedeh Masomeh Hosseini Valami
Position
Assistant Professor/Anesthesia
Other areas of specialty/work
Street address
Shahid Bahonar Blv, Qazvin City
City
Qazvin
Postal code
Phone
+98 28 1333 4810
Fax
Email
smhosseiniv@qums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin, University of Medical Sciences
Full name of responsible person
Dr Seyedeh Masomeh Hosseini Valami
Position
assistant professor/anesthesia
Other areas of specialty/work
Street address
Shahid Bahonarblv, Qazvin City
City
Qazvin
Postal code
Phone
+98 28 1333 4810
Fax
Email
smhisseinhv@qums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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