Clinical trial NCT06689124: A Randomized Study Comparing of Three Doses Nebulized Fentanyl in Older Adults
Official title: A Randomized Study Comparing of Three Doses Nebulized Fentanyl in Older Adults with Severe Musculoskeletal Pain At the Emergency Department
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Treatment Side Effects
Musculoskeletal Pain
Keywords: fentanyl
opioid
nebulized
musculoskeletal pain
elderly
emergency room
randomized controlled trial
Thai
Lead sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Navamindradhiraj University
First posted: 2024-11-14
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age more than or equal 65 years old.
* Presented with musculoskeletal pain within 3 days.
* Pain score on verbal numeric rating scale ≥ 5.

Exclusion Criteria:

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

Primary outcomes:
measure: Efficacy in pain reduction following nebulized fentanyl administration at different dosages.
timeFrame: 30 Minutes
Secondary outcomes:
measure: Adverse events following nebulized fentanyl administration at different dosages.
timeFrame: 0, 15, 30, 45, 60, 75, 90, 105, 120 Minutes
measure: Events of rescue therapy following nebulized fentanyl administration at different dosages.
timeFrame: 30, 45, 60, 75, 90, 105, 120 Minutes
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine,Vajira Hospital
city: Bangkok
country: Thailand
facility: Jiraporn Sri-on
Study officials:
affiliation: Faculty of medicine, Vajira hospital
name: Supavit Punyapatipan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of medicine, Vajira hospital
name: Jiraporn Sri-on, M.D.
role: PRINCIPAL_INVESTIGATOR
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