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

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Status: Active, not recruiting

Conditions: Musculoskeletal Pain; Treatment Side Effects

Treatments: Drug: Nebulized fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT06689124

219/66 FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 65 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Nebulized fentanyl 2 mcg/kg

Active Comparator group

Description:

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 kilogram of body weight (calculated based on the patient'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 nebulization.

Treatment:

Drug: Nebulized fentanyl

Nebulized fentanyl 3 mcg/kg

Active Comparator group

Description:

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 3 micrograms per kilogram of body weight (calculated based on the patient'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 nebulization.

Treatment:

Drug: Nebulized fentanyl

Nebulized fentanyl 4 mcg/kg

Active Comparator group

Description:

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 4 micrograms per kilogram of body weight (calculated based on the patient'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 nebulization.

Treatment:

Drug: Nebulized fentanyl