The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the treatment of acute severe pain in the emergency department. The investigators primary hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in Emergency Department patients aged 21-64 years. The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
350
Montefiore Medical Center Moses Division Emergency Department
The Bronx, New York, United States
Number of Patients With Satisfactory Pain Management at 60 Minutes
The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes. This is defined as the number of patients who declined additional pain medication at 60 minutes.
Time frame: 60 minutes
Mean Change in Pain Intensity From Baseline to 60 Minutes
Pain intensity is measured in numerical rating scale (NRS) units from 0 ("no pain") to 10 ("worst pain imaginable"). The change here represents the NRS score given by the patients at 60 minutes subtracted from the score at baseline, before treatment in the Emergency Department.
Time frame: 60 minutes
Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes
Time frame: 60 minutes
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