Montefiore Medical Center Emergency Department
The Bronx, New York, 10467, United States
NCT Number: NCT00825370
We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the patients receives whatever IV opioid the treating physician wants to give, in whatever dose.
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Notify Me21 year–64 year
All sexes
Interventional
Phase 3
The Bronx, New York, 10467, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
Other names: Dilaudid
Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
Other names: Discretionary care
Time frame: 60 minutes
Successful treatment was defined as either declining additional pain medication when asked at 15 minutes or accepting additional pain medication at 15 minutes but then declining additional pain medication at 60 minutes
Time frame: 15 min
As defined by the percentage of patients who answer "no" to the question, "Do you want more pain medication?" at 15 minutes
Time frame: 60 minutes
Patients who did not want pain medication determined by those who answered "no" to the question "do you want more pain medication?" at 60 minutes after treatment.
Time frame: Up to 60 minutes
Mean change in pain intensity between baseline and 15 minutes and between baseline and 60 minutes post treatment. Pain intensity is measured on a numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable"). The averages were calculated by finding the mean of change in pain intensity for each patient.
Montefiore Medical Center
Other
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