Safety Study of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg for Adult ED Patients
Recruitment status was Active, not recruiting
We wish to examine the safety and speed of onset of giving a dose of 1mg hydromorphone followed by an additional 1mg. Eligible patients will be given 1 mg IV hydromorphone. At 15 minutes, these patients will be asked the question, "Do you need more pain medication?" Those that answer "yes" will receive an additional 1mg IV hydromorphone. Those that answer "no" will not receive additional pain medications at that time period (15 minutes). Thus, we wish to give up to 2 mg IV hydromorphone titrated to patients' pain, which we believe will result in less incidence of oxygen desaturation.
If our study shows that this regimen is safe, its efficacy can be assessed in future trials. Positive results of those trials may lead to the use of this regimen to improve pain management in the emergency department.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Speed of Onsent of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg in the Treatment of Adult ED Patients With Moderate to Severe Pain|
- Incidence of a serious adverse event by 120 minutes post infusion, which is defined as the use of naloxone as a reversal agent [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Andrew Chang, M.D.||Motefiore Medical Center|