Comparing Intravenous Hydromorphone to Usual Care
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      In this randomized controlled trial, 2 mg intravenous (IV) hydromorphone will be more
      efficacious than usual care (usual care is analgesic management according to the judgment of
      the attending physician caring for that patient) in emergency department (ED) patients aged
      21-64 years. The primary efficacy outcomes are the proportion of patients in each arm who
      choose to forgo additional pain medication in 30 minutes of entry into the study and the
      change in numerical rating scale (NRS) pain scores from baseline to 30 minutes post baseline.
    

Detailed description: 
      Patients were randomized to the 2 mg IV hydromorphone group or usual care; allocation was
      generated with www.randomization.com, using sealed opaque envelopes opened in sequential
      order by the research assistants (RAs) immediately following enrollment. Patients randomly
      allocated to usual care received an initial dose of IV opioid; the type and dose of which was
      determined by the treating emergency physician (EP). Patients in the 2 mg hydromorphone group
      were allocated to receive 2 mg IV hydromorphone, administered slowly over 2 to 3 minutes. All
      patients were placed on 2 L O2 by nasal cannula. Subjects were blinded to the treatment they
      were assigned. At 30 minutes, both groups were asked the following scripted question: "Do you
      want more pain medication?" Patients in either group who answered or otherwise indicated
      "yes" had their treating attending physician notified, who then decided on further pain
      management. Those who answered or otherwise indicated "no" did not receive additional
      analgesic at that time. Attending physicians were thus able to treat patients' pain in any
      manner they deemed fit once this primary study endpoint was reached. In addition to
      acquisition of the primary endpoint, patients were also asked to rate their pain on a
      previously validated and reproducible standard verbal NRS ranging from 0 ("no pain") through
      10 ("worst pain possible") at 15, 30, 45, 60, 90, and 120 minutes following administration of
      the initial opioid dose at time 0. For safety reasons, patients were monitored for a total of
      120 minutes (i.e., 90 minutes past the primary study endpoint) to determine adverse effects.
      Systolic blood pressure, heart rate, oxygen saturation, nausea, vomiting, and pruritus were
      assessed at baseline and at 15, 30, 45, 60, 90, and 120 minutes after initial administration
      of opioid. Patients who experienced oxygen desaturation (defined as < 95%) were gently
      aroused if sleeping, asked to take several deep breaths, and repositioned into a sitting
      position if they had been in a reclined position. Nasal cannula oxygen was also increased to
      4 L, and the treating attending physician was notified. Subsequent management, including the
      use of naloxone, was per the treating attending physician's discretion.
    

Intervention name(s): Hydromorphone; Usual care
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg IV hydromorphone over to 2-3 minutes; Attending administers IV opioid of his choosing
Other intervention name(s): Dilaudid; Opioids
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acute; Pain; Emergency Department; Hydromorphone; Protocol