The aim of this study was to compare the effect of intravenous acetaminophen as a 24-hour drip or routine administration on pain control in patients undergoing cesarean section.
Design
A prospective double-blind randomized clinical trial; phase 3, with parallel groups; on 80 patients who were randomly assigned to the study and placed in groups A or B.
Settings and conduct
The statistical population of our study includes pregnant women who had been referred to Isfahan Family Hospital for cesarean section during 2018.
All patients underwent routine GA or spinal anesthesia and then the patients were randomly divided into two groups. For one group, acetaminophen was administered as a 24-hour intravenous drip (group A) and for the other group, intravenous acetaminophen was administered routinely (group B). At the end, the results were analyzed with SPSS software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 16 to 40 years; ASA 1.2; Candidate for a cesarean section; Do not smoke or use opioids.
Exclusion criteria: Sensitivity to any of the drugs used in the study; Having liver disease; History of seizures.
Intervention groups
Group A: 24-hour intravenous acetaminophen drip. Group B: Routine intravenous acetaminophen injection.
Main outcome variables
Post Operative Pain; Blood Pressure; Heart Rate; Pain Killer Consumption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180708040381N3
Registration date:2022-02-17, 1400/11/28
Registration timing:retrospective
Last update:2022-02-17, 1400/11/28
Update count:0
Registration date
2022-02-17, 1400/11/28
Registrant information
Name
Mehdi Izadi Zaman Abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3272 4538
Email address
mimi_izadi2@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2017-10-23, 1396/08/01
Actual recruitment end date
2018-10-27, 1397/08/05
Trial completion date
2018-10-27, 1397/08/05
Scientific title
Comparison of intravenous acetaminophen effect with 24-hour and routine drip on control of pain in patients undergoing cesarean section
Public title
The effect of acetaminophen drip on pain after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 16 to 40 years
Candidate for cesarean section
No smoke and opioids consumption
ASA class 1 or 2
Exclusion criteria:
Allergy to any of the drugs used in study
Liver disease
History of seizure
Age
From 16 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The women who met the inclusion criteria were randomly divided into two groups 1 and 2. In this way, the patients referred in group 1 on even days and the patients referred in group 2 on odd days.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients referred to each group as well as the person who recorded the patients' details did not know how to classify.
The person taking the drip acetaminophen or acetaminophen routinely did not know which person was in group A or B. The researcher and the evaluator knew what the patient group was.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University , Najaf Abad Branch
Street address
Islamic Azad University, Najaf Abad Branch, University Boulevard, Najaf Abad, Isfahan
City
Najaf Abad
Province
Isfehan
Postal code
8514143131
Approval date
2018-09-27, 1397/07/05
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1397.086
Health conditions studied
1
Description of health condition studied
post operative pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain Score
Timepoint
First 24 hr After Surgery Every 6 hr
Method of measurement
VAS Score
Secondary outcomes
empty
Intervention groups
1
Description
After the patient was fully conscious and in recovery in the 24-hour drip group, 2 mg / kg morphine and 4000 mg of acetaminophen were poured into the PCA pump and injected into the patient within 24 hours. Patients' VAS was evaluated in recovery at 6 hours, 12 hours, 18 hours and 24 hours after surgery, respectively. The acetaminophen used in this study was the so-called Apotel brand (manufactured in Greece and distributed by Koble Drug), which was used in 1000 mg ready-to-inject vials. The onset time of analgesic effect is 5 to 10 minutes and the maximum effect time is one hour and the duration of its effect is 4-6 hours. The PCA pump used was called Starmed, made in China, with a maintenance dose setting of 4 to 6 cc per hour with a 15-minute bolus interval for 24-hour acetaminophen drip.
Category
Treatment - Drugs
2
Description
In the routine intravenous acetaminophen group, only 2 mg / kg morphine was poured into the PCA pump and 1000 mg intravenous acetaminophen was injected into the patient every 6 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Family hospital
Full name of responsible person
Mehran Gheibi MD
Street address
Three ways hakim nezami, soffeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8639881747
Phone
+98 31 3620 1392
Email
info@khanevadeh-hospital.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Azad Islamic University, Najaf Abad Branch
Full name of responsible person
Farid Naimi
Street address
Azad Islamic University, Najaf Abad Branch, University Boulevard, Najaf Abad
City
Najaf Abad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4229 2929
Email
president@iaun.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad Islamic University, Najaf Abad Branch
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Izadi Zaman Abadi
Position
Aneshtesiology Expert
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No6.Pirooz Building, North Mejmar Ave. Manouchehri Ave. Ferdoosi Ave
City
Isfahan
Province
Isfehan
Postal code
8143834438
Phone
0098312724538
Email
mimi_izadi2@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Izadi Zaman Abadi
Position
Aneshthesiology Expert
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No6. Pirooz Building. North Mejmar Ave. Manoucheri Ave.Ferdoosi Ave
City
Isfahan
Province
Isfehan
Postal code
8143834438
Phone
0098312724538
Email
mimi_izadi2@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Izadi Zaman Abadi
Position
Aneshthesiology Expert
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No6. Pirooz Building. North Mejmar Ave. Manoucheri Ave.Ferdoosi Ave
City
Isfahan
Province
Isfehan
Postal code
8143834438
Phone
0098312724538
Email
mimi_izadi2@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All content and study data will be shared after publication.
When the data will become available and for how long
Access will start from the time the article is published.
To whom data/document is available
All authors and managing director of the publication
Under which criteria data/document could be used
To use the contents of this study in dissertations or articles,Students and researchers have access to the documents of this study.
From where data/document is obtainable
Dr Mehdi Izadi Zaman Abadi
Address: No6. Pirooz Building. North Mejmar Ave. Manoucheri Ave.Ferdoosi Ave
Post Code: 8143834438
E-mail: mimi_izadi2@yahoo.com
Tel: 00989131043958
What processes are involved for a request to access data/document
Email or request will be read,and after consulting with other authors, the request will be reviewed and answered.