At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 224 enrolled
Drug / intervention
Hydromorphone +1 moredrug
Likely dose
Hydromorphone 1mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Trial Comparing Protocolized Versus Non-protocolized Treatment of Adult ED Patients With Acute Severe Pain
In Brief
A Phase 3 clinical trial evaluating Hydromorphone and Nonprotocolized for Acute Pain. Completed, enrolled 224 participants across 1 site.
Detailed Summary
Patients treated with protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg IV hydromorphone if the patient wants more) will have better pain relief and no more adverse events than patients receiving non-protocolized pain management.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
Primary CompletionMar 2008
First PostedMar 2008
TodayJul 2026
First PostedMar 3, 2008
Enrollment StartDec 1, 2007
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 18.3 years ago
Interventions
Hydromorphonedrug
Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes
Nonprotocolizeddrug
An IV opioid the type and dose of which will be determined by the treating clinician