Acute Pain Clinical Trial
Official title:
Safety and Speed of Onset of a Fixed Dose of Intravenous Hydromorphone in the Treatment of Adult Patients Presenting to the Emergency Department With Acute Severe Pain
Verified date | August 2018 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the safety and speed of onset of 2mg intravenous hydromorphone (Dilaudid) in patients weighing at least 150 lbs presenting to the emergency department with acute severe pain
Status | Completed |
Enrollment | 298 |
Est. completion date | October 2006 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Age greater than 21 years 2. Age less than 65 years of age 3. Pain with onset within 7 days 4. ED attending physician's judgment that patient's pain warrants use of morphine 5. Normal mental status Exclusion Criteria: 1. Prior use of methadone 2. Use of other opioids or tramadol within past seven days 3. Prior adverse reaction to hydromorphone. 4. Chronic pain syndrome 5. Alcohol intoxication 6. SBP <90 mm Hg 7. Use of MAO inhibitors in past 30 days 8. C02 measurement greater than 46 |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Requiring Naloxone | Naloxone is a reversal agent - a medication that reverses the effects of another. Hydromorphone is an opiate pain medication that acts as a depressant to the body, thereby slowing it down. A large slow down is dangerous, as it can cause the breathing rate to slow down too much and prevent enough oxygen from entering the body and reaching the brain, resulting in death. Naloxone is a medication that blocks the receptors binding opiate pain medication and reversing the body's reaction to the hydromorphone, allowing body processes to return to normal speeds, including the breathing rate. The use of naloxone in the study indicates that the participant received too much pain medication or reacted more strongly than the average person, requiring the rescue medication to reverse the negative effects. The number of participants who required naloxone is assessed. | immediately after infusion, up to 120 minutes post infusion | |
Secondary | Number of Participants Experiencing a Respiratory Rate Lower Than 12 Breaths Per Minute | Normal respiratory rate ranges from 12 to 20 breaths per minute. The decreased respiration results in a decreased amount of oxygen entering the body and therefore low amount of oxygen supplied to the brain. Prolonged oxygen deprivation can result in injury or death. Respiratory rates lower than 12 breaths per minute is a sign of distress. Number of participants experiencing a respiratory rate lower than 12 breaths per minute is measured. | immediately after infusion, up to 120 minutes post infusion | |
Secondary | Number of Participants Experiencing a Systolic Blood Pressure Less Than 90 mmHg | Normal systolic blood pressure is approximately 120 mmHg. A low systolic blood pressure indicates blood, and therefore oxygen, are not being distributed around the body properly. This leads to a decreased amount of oxygen for the body to use and can result in injury or death if prolonged or severe. | Immediately after infusion, up to 120 minutes post infusion | |
Secondary | Oxygen Desaturation Measured Over 2-hour Time Frame | blood oxygen saturation less than 95% is considered oxygen desaturation. Blood oxygen saturation is normally above 95%. Oxygen desaturation of less than 90% is dangerous because there is less oxygen throughout the body for cellular energy. Prolonged or severe blood oxygen desaturation can result in injury or death. | immediately after infusion, up to 120 minutes post infusion | |
Secondary | Oxygen Saturation Measured Over 2-hour Time Frame | blood oxygen saturation is measured periodically from 1 minute to 120 minutes after the medication was infused | baseline to 120 minutes post infusion |
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