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

NCT04937946 | Unknown Phase 4

• 1 other identifier: 3491
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse effects of fentanyl

  5 days

Study Arms (2)

Fentanyl

EXPERIMENTAL

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

Placebo

NO INTERVENTION

Will receive continuous infusion of IV fluid up to 5 days or until the end of mechanical ventilation (if interrupted before 5 days ).

Interventions

Fentanyl DRUG

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 .

Fentanyl

Eligibility Criteria

• Age: 1 Hour - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• BSMMU

  Bngabandhu Sheikh Mujib Medical University

  STUDY CHAIR

Central Study Contacts

Kundan Dr Kundan Kumar Yadav, Resident

CONTACT

+8801782443116; kundanyadav1111@gmail.com

Dr Sadeka Choudhury Moni, A. Professor

CONTACT

+8801716294371; sadeka.moni.08@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: June 24, 2021
• Study Start: August 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: August 2021 to July 2022
• Access Criteria: After the approval of Institutional Review Board