The aim of this study is the effect of Pethidine administration on feeding behavior and physiological parameters in newborns delivered by cesarean with spinal anesthesia. This study is a randomized clinical trial on 116 pregnant women undergoing non-emergency cases admitted to Gerash-Iran hospital will be done. The main condition Inclusion is mother's wish to breastfeed her infant and the main conditions excluded is birth weight infants too little or too much weight, and low Apgar score. At first, the researcher's assistance educates the standard breastfeeding method for all mothers who have been admitted to study. After the spinal anesthesia and the end of the cesarean section in the intervention group, a single dose of 100 mg of pethidine is given by the anesthesiologist. In the control group, routine care (diclofenac suppository 100 mg) will be performed. With the onset of breastfeeding, researcher and research assistant record feeding behavior and physiologic parameters in two groups and will continue until 48 hours later. Variables include the feeding behavior, arterial PO2, heart rate, respiratory rate, and temperature of infants.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042233163N2
Registration date:2017-08-14, 1396/05/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-14, 1396/05/23
Registrant information
Name
zohre montaseri
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 2884
Email address
montaseriz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences
Expected recruitment start date
2017-07-11, 1396/04/20
Expected recruitment end date
2017-10-12, 1396/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Pethidine administration on feeding behavior and physiological parameters in newborns delivered by cesarean with spinal anesthesia
Public title
Pethidine effect on feeding behavior and physiological parameters of the infant
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: mothers of childbearing age; The candidates are non-emergency cases; gestational age between 38 to 42 weeks; singleton pregnancy; tend to breastfeeding 6-ASAΙ (Anesthesia class specified by the Anesthesiologist); No history of mental illness and depression; Would like to participate in the study.
Exclusion criteria: birth weight less than 2500 and more than 4,000 grams; First or fifth minute Apgar score less than seven; Meconium-stained amniotic fluid; Any abnormalities in the infant; using contraindicated drugs during breastfeeding; Formula feeding or bottle feeding; reluctant mother to continue to participate in the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University Of Medical Sciences, Zand Avenue, Shiraz, Iran
City
Shiraz
Postal code
1433671348
Approval date
2017-07-09, 1396/04/18
Ethics committee reference number
IR.SUMS.REC.1396.65
Health conditions studied
1
Description of health condition studied
The effect of Pethidine administration on feeding behavior and physiological parameters in newborns delivered by cesarean with spinal anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Feeding behavior
Timepoint
Three months after the start of the study
Method of measurement
Infant Breastfeeding Assessment Tool (IBAT)
Secondary outcomes
1
Description
Oxygen saturation
Timepoint
Three months after the start of the study
Method of measurement
Pulse oximeter
2
Description
Pulse rate
Timepoint
Three months after the start of the study
Method of measurement
Pulse oximeter
3
Description
Breathing
Timepoint
Three months after the start of the study
Method of measurement
Observation
4
Description
Body temperature
Timepoint
Three months after the start of the study
Method of measurement
Digital thermometer
Intervention groups
1
Description
Intervention group: administration of 100 mg of pithidine intravenous infusion after the Cesaren section
Category
Treatment - Drugs
2
Description
Control group: In this group was not given any narcotic drug. And non-opioid drugs such as diclofenac suppository is used to control pain.