Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Montefiore Medical Center.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Montefiore Medical Center
First received: March 4, 2011
Last updated: September 15, 2011
Last verified: March 2011
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
||Randomized Clinical Trial Comparing Two Protocols Using IV Hydromorphone
Primary Outcome Measures:
Secondary Outcome Measures:
- Number of participants with hypotension (SBP < 90 mmHg) [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
The incidence of hypotension from start of study until 120 minutes.
- Number of participants with bradycardia (HR < 50/min) [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
Number of participants with bradycardia (HR < 50/min) within 120 minutes.
- Number of patients with nausea and vomiting [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
Number of patients with nausea and vomiting within 120 minutes
- Number of participants with pruritus [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
Number of participants with pruritus within 120 minutes
- Number of participants needing naloxone as a reversal agent [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
Number of participants needing naloxone as a reversal agent within 120 minutes
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
2 mg IV hydromorphone
2 mg IV hydromorphone
1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?"
1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
|Ages Eligible for Study:
||21 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Age greater than 21 years and less than 65 years: This is a study of non-elderly adult patients. In addition, patients aged 21 years and younger are automatically triaged to the Children's ED.
- Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature.
- ED attending physician's judgment that patient's pain warrants IV opioids
- Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
- Prior adverse reaction to opioids.
- Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
- Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
- SBP <90 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
- Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
- Use of MAO inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
C02 measurement greater than 46: In accordance with standard protocol, three subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46 then the patient will be excluded from the study. The 3 subsets are as follows:
- All patients who have a history of COPD
- All patients who report a history of asthma together with greater than a 20 pack-year smoking history
- All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01311895
|Montefiore Medical Center Moses Division Emergency Department
|Bronx, New York, United States, 10467 |
|Contact: Andrew Chang, MD, MS 718-920-6626 firstname.lastname@example.org |
|Principal Investigator: Andrew K Chang, MD, MS |
Montefiore Medical Center
No publications provided
||Montefiore Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 4, 2011
||September 15, 2011
||United States: Institutional Review Board
Keywords provided by Montefiore Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Nervous System Diseases
Signs and Symptoms
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents