Efficacy and Safety of Fentanyl for Pain Control in Newborn on Mechanical Ventilation

Efficacy and Safety of Fentanyl for Pain Control in Newborns on Mechanical Ventilation

The purpose of the study is to assess the efficacy and safety of Fentanyl for pain control in Newborns on mechanical ventilator.

Study Overview

• Status: Not yet recruiting
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Drug: Fentanyl

Detailed Description

This Randomized Controlled Trial will be conducted in the Department of Neonatology, BSMMU, Dhaka after approval by Institutional Review Board (IRB). A Written informed consent will be obtained before enrollment in the study from the parents or guardians. . The study cohort will comprise all inborn and outborn newborns admitted to the neonatal intensive care unit (NICU) who receive mechanical ventilation administered through an endotracheal tube . The enrolled neonates will be randomly assigned with computer-generated random number tables via software named 'Random Allocation Software', to receive either of the intervention.

Once the parents will agree to the study and provide signed informed consent, all eligible neonates will be randomized to start treatment within 24 hours from the initiation of mechanical ventilation. Randomized infants will be allocated to the fentanyl group to receive a continuous infusion of fentanyl or to the placebo group to receive a continuous infusion of iv fluid.

Fentanyl will be administered as an intravenous loading dose of 1 microgram/kg in 30 minutes, followed by a continuous intravenous infusion of 1μg/kg/hour. The infusion will be administered through a peripheral line. Fentanyl infusion will be initiated within 24 hours after the start of mechanical ventilation and will be continued until the end of mechanical ventilation, and not longer than 5 days .

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kundan Dr Kundan Kumar Yadav, Resident; Phone Number: +8801782443116; Email: kundanyadav1111@gmail.com
• Study Contact Backup: Name: Dr Sadeka Choudhury Moni, A. Professor; Phone Number: +8801716294371; Email: sadeka.moni.08@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. All inborn and outborn newborns admitted to the neonatal intensive care unit (NICU) who received mechanical ventilation administered through an endotracheal tube.
2. Newborn on mechanical ventilator for at least 72 hours.

Exclusion Criteria:

1. Known genetic or chromosomal disorders,
2. The need for postoperative analgesic therapy during the study period,
3. Major congenital anomaly,
4. Those who received drugs like midazolam, paracetamol, morphine, muscle relaxants, phenobarbital, phenytoin, and chloral hydrate during the study period.
5. Probable rapid extubation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fentanyl; Fentanyl will be given within 24 hours from the initiation of mechanical ventilation at an intravenous loading dose of 1 microgram/kg in 30 minutes, followed by a continuous intravenous infusion of 1μg/kg/hour up to 5 days or until the end of mechanical ventilation (if interrupted before 5 days ).	Drug: Fentanyl; Fentanyl will be administered as an intravenous loading dose of 1 microgram/kg in 30 minutes, followed by a continuous intravenous infusion of 1μg/kg/hour. The infusion will be administered through a peripheral line. Fentanyl infusion will be initiated within 24 hours after the start of mechanical ventilation and will be continued until the end of mechanical ventilation, and not longer than 5 days .
No Intervention: Placebo; Will receive continuous infusion of IV fluid up to 5 days or until the end of mechanical ventilation (if interrupted before 5 days ).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in Neonatal Pain Agitation and Sedation Scale (NPASS) score.	If fentanyl is able to decrease NPASS pain score. Total score is 13. A mean difference of 3 points will be considered clinically relevant.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects of fentanyl	Duration of mechanical ventilation (hours); chest wall rigidity (evaluated by clinical observation), diuresis, hypotension	5 days

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Investigators: Study Chair: BSMMU, Bngabandhu Sheikh Mujib Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: June 19, 2021
• First Submitted That Met QC Criteria: June 19, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: 3491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the approval of Institutional Review Board
• IPD Sharing Time Frame: August 2021 to July 2022
• IPD Sharing Access Criteria: After the approval of Institutional Review Board

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No