Replacement of intravenous acetaminophen for fentanyl to control pain after thoracic and abdominal surgeries in neonates
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
This randomized controlled study will be done in neonatal intensive cares unit of Urmia Shahid Motahary and Shiraz Namazi hospitals on 66 neonates.Then neontes will be divided to 2 groups, randomly. One group will receive acetaminophen and the other group will receive fentanyl . If in each group pain scale is more than 7 they receive one dose of fentanyl which is reliefing dose. the relief dose. If relief doses in both groups gone out of 3 doses, that case would be excluded from the study.
Participants/Inclusion and exclusion criteria
Inclusion: Neonates with gestational age of 36 weeks and more with thoracic or abdominal surgery
Exclusion: Neonates with allergy to morphine, fentanyl or acetaminophen or hepatic or renal dysfunction
Intervention groups
Neontes will be divided to 2 groups, randomly. One group will recieve fentanyl , and the other group will recieve acetaminophen .
Main outcome variables
The main variable in our study is effective pain control after abdominal or thoracic surgeries in neonates.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171218037936N2
Registration date:2019-03-11, 1397/12/20
Registration timing:prospective
Last update:2019-03-11, 1397/12/20
Update count:0
Registration date
2019-03-11, 1397/12/20
Registrant information
Name
Kamran Dehghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3365 4154
Email address
dehghan.k@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effect of intravenous acetaminophen and fentanyl in thoracic and abdominal surgery of neonates
Public title
Comparison of the analgesic effect of intravenous acetaminophen and fentanyl (opiate analgesic) in thoracic and abdominal surgery of neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neonates with gestational age of 36 weeks and more with thoracic surgery
Neonates with gestational age of 36 weeks and more with abdominal surgery
Exclusion criteria:
Allergy history to morphine, fentanyl or acetaminophen
Hepatic dysfunction
Renal dysfunction
Age
From 1 day old to 28 days old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
We will use blocked randomization method in order to allocate cases to two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Only the researcher knows double blindness, who is different from clinical care giver. As the study cases are neonates, and evaluation is based on behavior and vital signs, there will be no need to blind the study cases.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Research deputy of Urmia university of medical sciences, Jahad square, Urmia, West Azarbayjan, Iran. A
City
Urmia
Province
West Azarbaijan
Postal code
5714615463
Approval date
2019-01-26, 1397/11/06
Ethics committee reference number
IR.UMSU.REC.1397.416
Health conditions studied
1
Description of health condition studied
Abdominal and Thoracic surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score
Timepoint
At the beginning of study and then every 6 hours up to 48 hours
Method of measurement
NIPS ( Neonatal Infant Pain Scale) Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:IV Acetaminophen !0 mg/kg every 6 hours up to 48 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari University hospital, Urmia University of Medical sciences and Namazi hospital of Shi