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

Phase 4
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
Registration Number
TCTR20240610005
Lead Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
All
Target Recruitment
120
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

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).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Efficacy in pain reduction following nebulized fentanyl administration at different dosages. 30 Minutes verbal numerical rating scale
Secondary Outcome Measures
NameTimeMethod
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
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