| Study name |
Comparing the effect of fentanyl and midazolam on the sedation of infants under mechanical ventilation: a randomized clinical trial |
| Methods |
Unblinded mono‐centre randomised controlled trial
Sample size: 60 newborns
Setting: Najmiyeh Hospital, Tehran, Iran |
| Participants |
Inclusion criteria: ventilated infants weighing between 2.5 and 4 kg
Exclusion criteria: congenital heart disease; brain anomalies; metabolic or chromosomal syndromes |
| Interventions |
Fentanyl 0.5 microg/kg
Midazolam 0.1 mg/kg |
| Outcomes |
Primary outcomes: duration of hospital stay; duration of mechanical ventilation
Secondary outcome: pneumothorax |
| Starting date |
Expected recruitment start date: 1 July 2016 |
| Contact information |
Mohammad Hossein Khosravi; dr.mhkhosravi@gmail.com |
| Notes |
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