Comparison of the effects of paracetamol ampoule and acetaminophen suppository in postoperative pain in children admitted to the pediatric surgery ward
Design
A clinical trial is implemented with two intervention groups (paracetamol and acetaminophen suppository), with parallel groups, single blind, randomized, and is performed on 70 children (35 children in the paracetamol group) and (35 children in the acetaminophen suppository group). Lottery is used for randomization.
Settings and conduct
The intervention is implemented in the pediatric surgery ward of Imam Ali Hospital in Zahedan, Iran. The intervention is performed on 70 children by simple random sampling. This research is performed as single- blind. In such a way that the co-researcher is not known, what kind of medicine (intervention) has been done for the child.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being candidate for abdominal surgery; no history of surgery in 1 recent year; do not received analgesic drug in the last 4 hours; no history of allergy to acetaminophen.
Exclusion criteria: complications such as diarrhea, vomiting, throat, severe headache.
Intervention groups
In the acetaminophen suppository group, the child's pain is assessed before the intervention. Acetaminophen suppositories (125 mg) are inserted into the baby's anus. One hour and 2 hours after the intervention, the pain is recorded again.
In the paracetamol ampule group, the child's pain is examined before the intervention. Paracetamol ampoule infused with 100 cc of 0.9% normal saline for 15 minutes. 1 hour and 2 hours after the intervention, the child's pain is re-recorded.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121025011261N4
Registration date:2021-03-02, 1399/12/12
Registration timing:prospective
Last update:2021-03-02, 1399/12/12
Update count:0
Registration date
2021-03-02, 1399/12/12
Registrant information
Name
Alia Jalalodini
Name of organization / entity
Nursing and Midwifery College
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 2481
Email address
jalalodini@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of paracetamol ampoule and acetaminophen suppository on postoperative pain control in children admitted to pediatric surgery department
Public title
The effect of paracetamol ampoule and acetaminophen suppository on postoperative pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being candidate for surgery on the abdominal organ.
Having the order of paracetamol ampoule and acetaminophen suppository as PRN on the patient file by physician.
Have not history of acetaminophen allergy.
Do not received analgesic drug in the last 4 hours.
Exclusion criteria:
Having complications such as diarrhea, vomiting, throat, and severe headache
Not collaborating of child or family
Age
From 1 year old to 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Samples divided randomly into two groups. As, we consider a code or number for each of the samples. Then, by lottery method, the samples will be assigned to two groups; paracetamol and acetaminophen suppositories.
Blinding (investigator's opinion)
Single blinded
Blinding description
The co- researcher not know what kind of medicine (intervention) has been accomplished for the child.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Janat Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745477
Approval date
2021-02-14, 1399/11/26
Ethics committee reference number
IR.ZAUMS.REC.1399.493
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
1 hour and 2 hours after receiving analgesia medicine
Method of measurement
Toddler –preschooler postoperative pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (1): in the group of acetaminophen suppository, the intensity of the child's pain is evaluated before the intervention. Then, according to the physician's order (PRN and based on weight), acetaminophen suppository (125 mg) is placed in the child's anal area with co-researcher.1 hour and 2 hours after acetaminophen suppository, the child's pain is examined and the pain score is recorded.
Category
Treatment - Drugs
2
Description
Intervention group (2): in the paracetamol ampule group, the child's pain intensity is examined before the intervention. After investigating the physician's order (PRN) and examining the dose of paracetamol ampoules (based on weight), the co-researcher mixes the ampoule with 100 cc of 0.9% normal saline and infused for 15 minutes. 1 hour and 2 hours after paracetamol injection, the child's pain intensity is re-evaluated and the pain score is recorded.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Abne Abitaleb Hospital related to Zahedan University of Medical Sciences and Health Services
Full name of responsible person
Alia Jalalodini
Street address
Ali Abne Abitaleb Hospital, Health Blvd, Persian Gulf Highway, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3341 9406
Email
a_jalalodini@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Normohammad Bakhshany
Street address
Zahedan University of Medical Sciences, Janat Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
histology@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
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
Zahedan University of Medical Sciences
Full name of responsible person
Alia Jalalodini
Position
Faculty member of science, Master of science in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty، Behdasht Blvd,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
a_jalalodini@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alia Jalalodini
Position
Faculty member of science, Master of science in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty، Behdasht Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2482
Email
a_jalalodini@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alia Jalalodini
Position
Faculty member of science, Master of science in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty، Behdasht Blvd,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2481
Email
a_jalalodini@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available