NCT06689124

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: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital · Other Government
• Sex: All
• Age: 65 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial compares three different nebulized fentanyl dosages for older persons experiencing severe musculoskeletal pain at the emergency department. The main objective is: Does the effectiveness of nebulized fentanyl at dosages of 2 mcg/kg, 3 mcg/kg, and 4 mcg/kg at 30 minutes differ in older patients who report to the emergency room with pain from musculoskeletal injuries? Secondary outcome are: 1. Incidence of adverse effects after drug administration at minutes 0, 15, 30, 45, 60, 75, 90, 105, 120 2. Incidence of receiving other pain relief treatments (rescue therapy) in minutes 30, 45, 60, 75, 90, 105, 120 Participants will receive an explanation of the study and possible side effects, which may take approximately 5-10 minutes, without affecting the primary treatment of the patients. Consent will be obtained in this study, along with signing or fingerprinting as evidence in the consent form.

Detailed description

Participants will receive nebulized fentanyl for pain reduction at the pre-determined randomized dose, then researchers will follow up assessments of pain levels, vital signs, and any side effects at various intervals.

Conditions

• Treatment Side Effects
• Musculoskeletal Pain

Interventions

Type	Name	Description
DRUG	Nebulized fentanyl	After the enrollment process, the main research assistant will take a brown envelope containing the randomization and hand it to the principal investigator in numerical order. The principal investigator will then open the envelope to determine the group assignment for the patient, revealing which fentanyl nebulization dosage group (2 mcg/kg, 3 mcg/kg and 4 mcg/kg) the patient will be placed in. In this study, participants will be divided into three groups as previously described. We evaluate pain score at 0, 15, 30, 45, 60, 75, 90, 105 and 120 minutes after receiving nebulized fentanyl by a train research assistance who is blind from the treatment dosage.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2024-11-14
• Last updated: 2024-11-14

Locations

2 sites across 1 country: Thailand