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ebulized fentanyl compared to intravenous morphine for acute pain management in the Emergency Room: a randomized controlled trial, double blinded trial

Phase 3
Recruiting
Conditions
In Thailand, there are no pain protocol for acute pain management in emergency setting, pain killer are based on doctor consideration
acute pain
Registration Number
TCTR20240624001
Lead Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
72
Inclusion Criteria

1.ED patients age 18-65 years
2.Acute severe pain reported as : VAS > 7

Exclusion Criteria

1.Hemodynamic instability(SBP < 90 / > 180, HR < 50 / > 150, RR < 10 / > 30, BW <40 / > 115 kg
2.Abdominal pain
3.Asthma/COPD
4.Cirrhosis, CKD (Cr.CL. < 30)
5.Pain medication used within 4 h
6.Abused MAOIs within 2 wk
7.Opioid used more than 10 days
8.Pregnancy/lactation
9.Intracerebral hemorrhage
10.Patient positive for COVID-19/influenza/RSV/TB
11.History of fentanyl/morphine/ naloxone/ondansetron allergy
12.Inability to self-reported pain score; Altered mental status(GCS <15), Communication barrier
13.Plastic allergy / claustrophobia

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain intensity reduction 15 min after received intervention Visual Analogue Scale (VAS)
Secondary Outcome Measures
NameTimeMethod
Pain intensity reduction 30, 45, 60 min post treatment Visual Analogue Scale (VAS),adverse events 15, 30, 45, 60 min post treatment record form,requirement for rescue therapy 15, 30, 45, 60 min post treatment record form
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