In this double blinded randomized controlled trial we will compare morphine and phentanyl in ventilated neonate. 32 patients with gestational age between 24 to 38 weeks are included. Patients with gestational age more than 24 weeks who need for ventilation will be included in the study ofter obtaining parents informed consent. Neonates with asphyxia, hyperbilirubinemia, hepatitis and biliary, urinary, cardiac, or gastrointestinal anomalies are excluded from the study. Patients will divided into two equal groups by closed envelop method. Patients in morphine group will receive a loading dose of 100mcg per hours and maintenance dose of 12mcg per kilogram per hours. Patients in phentanyl group will receive 2mcg phentanyl in one hour intravenously followed by 1.4mcg per kilograms per hours. Two groups will be compared for systemic blood pressure, urinary retention, and drug side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105216532N1
Registration date:2012-09-18, 1391/06/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-18, 1391/06/28
Registrant information
Name
Salma Naderi
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 1666 6240
Email address
snaderi@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2012-08-20, 1391/05/30
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of side effects of morphine and fentanyl in infants undergoing mechanical ventilation in the intensive care unit
Public title
Analgesic effects of opiates on neonates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Gestational age more than 24 weeks; Need for ventilation because of respiratory distress; Parents informed consent
Exclusion criteria: Asphyxia; Hyperbilirubinemia; neonatal hepatitis; Biliary duct anomalies; Urinary system anomalies; cardiac anomaleis; gastroiuntestinal obstruction
Age
From 1 year old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hormozgan University of Medical Sciences
Street address
Shahid Mohammadi Hospital
City
Bandar Abbas
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
HEC-9-5-2
Health conditions studied
1
Description of health condition studied
Respiratory Distress Syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Systolic Blood Pressure
Timepoint
Baseline, 2nd day
Method of measurement
Mercury barometer
Secondary outcomes
1
Description
Urinary retention
Timepoint
Baseline, 2nd Day
Method of measurement
Diagnosed by specialist
Intervention groups
1
Description
100mcg per kilograms morphine in 1 hours followed by 12 mcg per kilograms per hours intravenous morphine
Category
Treatment - Drugs
2
Description
2 mcg phentanyl per kilogram followed by 1.4 mcg per kilogram per hours intravenously
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Koodakan hospital
Full name of responsible person
Dr Salma Naderi
Street address
Koodakan Hospital, Golshahr
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Azim Nejatizadeh
Street address
Koodakan hospital
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan 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
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Salma Naderi
Position
Neonatalogist
Other areas of specialty/work
Street address
Koodakan Hospital, Golshahr
City
Bandar Abbas
Postal code
Phone
+98 76 1333 7192
Fax
Email
salmanaderi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Salma Naderi
Position
Neonatalogist
Other areas of specialty/work
Street address
Koodakan Hospital, Golshahr
City
Bandar Abbas
Postal code
Phone
+98 76 1333 7192
Fax
Email
salmanaderi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Salma Naderi
Position
Neonatalogist
Other areas of specialty/work
Street address
Koodakan Hospital
City
Bandarabbas
Postal code
Phone
+98 76 1333 3280
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)