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NCT Number: NCT06689124

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Treatment Side Effects Disease Attributes Emergencies Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine,Vajira Hospital, Bangkok, Thailand

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Nebulized fentanyl

Drug

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.

Other names: Nebulized fentanyl dosage

Primary outcomes

  1. Efficacy in pain reduction following nebulized fentanyl administration at different dosages.

    Time frame: 30 Minutes

    Efficacy in pain reduction following nebulized fentanyl administration at dosages of 2 mcg/kg, 3 mcg/kg, and 4 mcg/kg in elderly patients presenting to the emergency department with musculoskeletal pain, using verbal numerical rating scale (VNRS) VNRS score ranges from 0 to 10, with a higher score indicating more severe pain. Ten indicates the worst pain, and zero indicates no pain.

Secondary outcomes

  1. Adverse events following nebulized fentanyl administration at different dosages.

    Time frame: 0, 15, 30, 45, 60, 75, 90, 105, 120 Minutes

    Adverse events following nebulized fentanyl administration at dosages of 2 mcg/kg, 3 mcg/kg, and 4 mcg/kg in elderly patients presenting to the emergency department with with musculoskeletal pain

  2. Events of rescue therapy following nebulized fentanyl administration at different dosages.

    Time frame: 30, 45, 60, 75, 90, 105, 120 Minutes

    Events of rescue therapy following nebulized fentanyl administration at dosages of 2 mcg/kg, 3 mcg/kg, and 4 mcg/kg in elderly patients presenting to the emergency department with musculoskeletal pain

Sponsors and collaborators

Lead sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Other Gov

Collaborators

  • Navamindradhiraj University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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