A Non-inferiority Randomized Controlled Trial Comparing Nebulized Fentanyl and Intravenous Morphine for Acute Pain Management in the Emergency Department

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240624001

Enrollment

Registered

2024-06-24

Start date

2024-05-21

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In Thailand, there are no pain protocol for acute pain management in emergency setting, pain killer are based on doctor consideration acute pain

Interventions

Nebulized fentanyl 4 micrograms per kilogram of body weight (calculated based on the patient&#039

s actual weight in kilograms). The medication was contained in a nebulizer. It was then mixed with normal saline (0.9% normal saline) to a total volume of 5 milliliters and administered via nebulizati

s actual weight in kilograms). The medication was contained in a syringe. It was then mixed with normal saline (0.9% normal saline) to a total volume of 10 milliliters and administered via injection.

Experimental Drug,Active Comparator Drug

Nebulized fentanyl,Intravenous morphine

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.ED patients age 18-65 years 2.Acute severe pain reported as : VAS > 7

Exclusion criteria

Exclusion criteria: 1.Hemodynamic instability(SBP < 90 / > 180, HR < 50 / > 150, RR < 10 / > 30, BW <40 / > 115 kg 2.Abdominal pain 3.Asthma/COPD 4.Cirrhosis, CKD (Cr.CL. < 30) 5.Pain medication used within 4 h 6.Abused MAOIs within 2 wk 7.Opioid used more than 10 days 8.Pregnancy/lactation 9.Intracerebral hemorrhage 10.Patient positive for COVID-19/influenza/RSV/TB 11.History of fentanyl/morphine/ naloxone/ondansetron allergy 12.Inability to self-reported pain score; Altered mental status(GCS <15), Communication barrier 13.Plastic allergy / claustrophobia

Design outcomes

Primary

Measure	Time frame
Pain intensity reduction 15 min after received intervention Visual Analogue Scale (VAS)	—

Secondary

Measure	Time frame
Pain intensity reduction 30, 45, 60 min post treatment Visual Analogue Scale (VAS),adverse events 15, 30, 45, 60 min post treatment record form,requirement for rescue therapy 15, 30, 45, 60 min post treatment record form	—

Countries

Thailand

Contacts

Public ContactPitchapar Preungprasob

Faculty of medicine Vajira hospital

pitchapar.pre@nmu.ac.th0863671436

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026