Montefiore Medical Center
The Bronx, New York, 10467, United States
NCT Number: NCT00195910
To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department (ED) with acute severe pain.
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Notify Me21 year–65 year
All sexes
Interventional
Phase 2
The Bronx, New York, 10467, United States
There is widespread agreement that pain is under-treated in the Emergency Department (ED). The current recommended treatment of acute pain in the ED setting is administration of an initial bolus of morphine followed by titration until adequate analgesia is achieved. Several studies have shown that even 0.1 mg/kg IV morphine (7-10 mg administered to the average 70-100 kg patient) inadequately treats many patients' acute pain. In spite of this, it has been observed that many emergency physicians and nurses are hesitant to give 7-10 mg of morphine as an initial IV dose. In contrast, it has been observed that these same healthcare providers were not similarly reluctant to administer a roughly equianalgesic dose of hydromorphone (1-1.5 mg), perhaps because the more potent hydromorphone is given in much smaller milligram quantities than morphine, thus providing the illusion of substantially less opioid administered to the patient. Having repeatedly observed this phenomenon, it is reasonable that if a smaller milligram dose of hydromorphone were shown to provide an efficacy, safety, and side-effect profile comparable or superior to a larger milligram dose of morphine, it would provide evidence supporting use of hydromorphone as an alternative first line opioid in the treatment of acute pain presenting to the ED. As a practical corollary to this, it is reasoned further that the increased willingness of healthcare providers to use hydromorphone might contribute to reducing one component of the multifaceted problem of oligoanalgesia in the ED.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.1 mg/kg IV morphine
0.015 mg/kg IV hydromorphone
Other names: Dilaudid
Time frame: baseline to 30 minutes after medication infused
Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable)
Time frame: 5 minutes after medication is given
Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 30 minutes after medication is given
Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 2 hours after medication is given
Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Time frame: baseline to 5 minutes after medication is given
Number of participants who experienced vomiting and required medication between baseline and 5 minutes after medication was infused
Time frame: 6 minutes after medication is given to 30 minutes after medication is given
Number of participants who experienced vomiting and required medication between 6 minutes after medication was infused and 30 minutes after medication was infused
Time frame: 31 minutes after medication is given to 120 minutes after medication is given
Number of participants who experienced vomiting and required medication between 31 minutes after medication was infused and 120 minutes after medication was infused
Time frame: baseline to 5 minutes after medication was infused
Number of participants for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between baseline and 5 minutes after medication was infused
Time frame: 6 minutes to 30 minutes after medication was infused
Number of patients for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between 6 and 30 minutes after the medication was infused
Time frame: 31 minutes to 120 minutes after medication was infused
Number of patients for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between 31 and 120 minutes after medication was infused
Montefiore Medical Center
Other
Safety and Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute, Severe Pain: A Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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