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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 19, 2008 | ||||
| Last Updated Date | May 21, 2008 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00682435 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety Study of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg for Adult ED Patients | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Single Group Assignment, Safety Study | ||||
| Condition ICMJE | Pain | ||||
| Intervention ICMJE | Drug: Hydromorphone | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 350 | ||||
| Completion Date | |||||
| Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 64 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00682435 | ||||
| Responsible Party | Andrew Chang, MD, Montefiore Medical Center | ||||
| Study ID Numbers ICMJE | MMC0702028 | ||||
| Study Sponsor ICMJE | Montefiore Medical Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Montefiore Medical Center | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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