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A Randomized Study Comparing of Three Doses Nebulized Fentanyl in Older Adults

A Randomized Study Comparing of Three Doses Nebulized Fentanyl in Older Adults With Severe Musculoskeletal Pain at the Emergency Department

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240610005
Enrollment
120
Registered
2024-06-10
Start date
2024-06-17
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

Treatment efficacy(Pain reduction after fentanyl nebulized), Treatment side effects(side effects after fentanyl nebulized) fentanyl, opioid, nebulized, musculoskeletal pain, elderly, emergency room, randomized controlled trial

Interventions

The researcher prepared fentanyl (the researcher informed the in-charge nurse to open the medicine cabinet and double-checked the dosage with the in-charge nurse). The dosage was 2 micrograms per kilo
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
Active Comparator Drug,Active Comparator Drug,Active Comparator Drug
Nebulized fentanyl 2 mcg/kg,Nebulized fentanyl 3 mcg/kg,Nebulized fentanyl 4 mcg/kg

Sponsors

Bangkok Metropolitan Administration Medical College and Vajira Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age more than or equal 65 years old. 2. Presented with musculoskeletal pain within 3 days. 3. Pain score equal to or greater than 5 on a verbal numeric rating scale.

Exclusion criteria

Exclusion criteria: 1. Patients need immediate intervention. 2. Patients need acute rescue for acute coronary syndrome, respiratory failure, and stroke. 3. Creatinine clearance < 30 ml/min, Cirrhosis stage III, IV (present with ascites and varices). 4. Trauma >2 organ. 5. Comorbidities of chronic obstructive pulmonary disease. 6. Take MAO inhibitors within 14 days. 7. History of opioid used within 8 hours. 8. History of alcohol or drug abuse. 9. History of fentanyl allergy. 10. Patients with difficulty to communication (e.g. altered mental status, severe dementia (define by 6-items cognitive screening > 12, language barrier).

Design outcomes

Primary

MeasureTime frame
Efficacy in pain reduction following nebulized fentanyl administration at different dosages. 30 Minutes verbal numerical rating scale

Secondary

MeasureTime frame
Adverse events following nebulized fentanyl administration at different dosages. 0, 15, 30, 45, 60, 75, 90, 105, 120 Minutes Side Effect Rating Scale for Dissociative Anesthetics (SERSDA), Richmond Agitation Sedation Scale ,Events of rescue therapy following nebulized fentanyl administration at different dosages. 30, 45, 60, 75, 90, 105, 120 Minutes Present of events of rescue therapy

Countries

Thailand

Contacts

Public ContactSupavit Punyapatipan

Faculty of medicine Vajira hospital

supavit.pun@nmu.ac.th0853516909

Outcome results

None listed

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