Comparing Intravenous Hydromorphone to Usual Care
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01429298|
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : April 20, 2018
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Hydromorphone Drug: Usual care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Clinical Trial Comparing Intravenous Hydromorphone to Usual Care|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.
2 mg IV hydromorphone over to 2-3 minutes
Other Name: Dilaudid
Active Comparator: Usual care
The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing
Drug: Usual care
Attending administers IV opioid of his choosing
Other Name: Opioids
- Number of Participants Who Declined Additional Medication at 30 Minutes [ Time Frame: 30 minutes ]Amount of patients who choose to forgo additional pain medication at 30 minutes post-baseline when asked the question, "Do you want more pain medication?"
- Mean Change in Pain Intensity Score From Baseline to 30 Minutes [ Time Frame: 30 minutes ]Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 ("no pain") to 10 ("worst pain imaginable"). The change in NRS score is calculated by subtracting the score at 30 minutes post treatment from the score at baseline, before treatment. The average of these values was calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429298
|United States, New York|
|Montefiore Emergency Department|
|Bronx, New York, United States, 10467|