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Protective effect of Fentanyl on oropharyngeal trauma in neonatal intubation
Last registered on May 06, 2016

Pre-Trial

Trial Information
General Information
Title
Protective effect of Fentanyl on oropharyngeal trauma in neonatal intubation
RCT ID
AEARCTR-0001224
Initial registration date
May 06, 2016
Last updated
May 06, 2016 4:04 PM EDT
Location(s)
Primary Investigator
Affiliation
Islamic Azad University
Other Primary Investigator(s)
Additional Trial Information
Status
Completed
Start date
2015-09-01
End date
2016-05-01
Secondary IDs
Abstract
Background: Endotracheal intubation is frequently performed in neonatal intensive care units. It is extremely distressing and painful and has been associated with significant neonatal morbidity. The aim of this study was to evaluate the efficacy and safety of Fentanyl as a premedication and its impact in accelerating the endotracheal intubation in neonates at the neonatal intensive care unit (NICU).
Methods: In this double blind randomized controlled trial study, newborns admitted to NICU of Alzahra Hospital ,Izadi Hospital and Hazrat Masumeh Hospital (in Qom city), requiring an elective endotracheal intubation were randomly assigned in two groups. For the case group Fentanyl was administered 3 mcg/kg slow IV push in 1 mL normal saline in five minutes before intubation, and the control group received 1 mL normal saline five minutes before intubation. From 5 minutes before the procedure until 5 minutes after that, heart rate(HR), blood pressure(BP) and arterial blood oxygen saturation were recorded and compared in both groups. The primary outcome was time to successful intubation.
External Link(s)
Registration Citation
Citation
Gharehbeglou, Mohammad. 2016. "Protective effect of Fentanyl on oropharyngeal trauma in neonatal intubation." AEA RCT Registry. May 06. https://doi.org/10.1257/rct.1224-1.0.
Former Citation
Gharehbeglou, Mohammad. 2016. "Protective effect of Fentanyl on oropharyngeal trauma in neonatal intubation." AEA RCT Registry. May 06. http://www.socialscienceregistry.org/trials/1224/history/8133.
Experimental Details
Interventions
Intervention(s)
Intervention Start Date
2015-12-01
Intervention End Date
2016-05-01
Primary Outcomes
Primary Outcomes (end points)
The aim of this study was to evaluate the efficacy and safety of Fentanyl as a premedication and its impact in accelerating the endotracheal intubation in neonates at the neonatal intensive care unit.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
In this prospective double-blind randomized controlled trial, newborns of gestational age ≥28 weeks postnatal ages less than 3 days admitted to the neonatal intensive care unit of Alzahra Hospital Izadi Hospital and Hazrat Masumeh Hospital (in Qom city),, Iran with length of stay at least 72 h requiring an elective endotracheal intubation or tube exchange were randomly assigned in two groups. Neonates with upper airway anomalies which made intubation difficult and cyanotic and congenital heart disease, neuromuscular diseases, and clinical syndromes were excluded from the study. Infants with 3 or more times of unsuccessful attempts of endotracheal intubation were also excluded. For the case group (n= 44), Fentanyl (made by Caspian Company, Iran country) was administered 3 mcg/kg slow IV push in 1 mL normal saline in five minutes before intubation, and the control group (n= 51) received 1 mL normal saline five minutes before intubation. From 5 minutes before the procedure until 5 minutes after that, heart rate, blood pressure and arterial blood oxygen saturation were recorded by Hewellett Packard monitor.
Prior to intubation, all neonates were ventilated with 100% oxygen for one minute to increase the SpO2 over 94%. Laryngoscopy was performed using the Riester laryngoscope by an expert nurse in NICU who was unaware about the type of the medication used.
The primary outcome was time to successful intubation which was from the time of laryngoscope insertion into the mouth until its removal after successful intubation and was recorded with chronometer by another nurse who was unaware of the type of the drug administered. Adverse events including difficulty in intubation due to the laryngospasm or the blood found due to the damage to the mucosa of the mouth and tracheal rupture were reported and compared in both groups.
Heart rate and arterial blood oxygen saturation changes before, during, and after the procedure were calculated. Blood pressure was not accessible during intubation due to the movement of neonates and it was only recorded before and after the procedure.
Experimental Design Details
Randomization Method
The participants were randomly assigned, following simple randomization procedures (1 : 1),
Randomization Unit
individual
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
95
Sample size: planned number of observations
1
Sample size (or number of clusters) by treatment arms
95
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Islamic Azad University
IRB Approval Date
2015-09-30
IRB Approval Number
18731138-Q
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports, Papers & Other Materials
Relevant Paper(s)
REPORTS & OTHER MATERIALS