Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain
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|ClinicalTrials.gov Identifier: NCT00305110|
Recruitment Status : Completed
First Posted : March 21, 2006
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Drug: 2 mg IV hydromorphone||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||298 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||October 2006|
Experimental: 2 mg IV hydromorphone
2 mg IV hydromorphone administered over 2-3 minutes
Drug: 2 mg IV hydromorphone
Other Name: Dilaudid
- Number of Participants Requiring Naloxone [ Time Frame: immediately after infusion, up to 120 minutes post infusion ]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.
- Number of Participants Experiencing a Respiratory Rate Lower Than 12 Breaths Per Minute [ Time Frame: immediately after infusion, up to 120 minutes post infusion ]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.
- Number of Participants Experiencing a Systolic Blood Pressure Less Than 90 mmHg [ Time Frame: Immediately after infusion, up to 120 minutes post infusion ]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.
- Oxygen Desaturation Measured Over 2-hour Time Frame [ Time Frame: immediately after infusion, up to 120 minutes post infusion ]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.
- Oxygen Saturation Measured Over 2-hour Time Frame [ Time Frame: baseline to 120 minutes post infusion ]blood oxygen saturation is measured periodically from 1 minute to 120 minutes after the medication was infused
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): NCT00305110
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Andrew K Chang, MD||Montefiore Medical Center|