Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone
|ClinicalTrials.gov Identifier: NCT01311895|
Recruitment Status : Completed
First Posted : March 10, 2011
Results First Posted : May 18, 2018
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Drug: H2O Drug: 1+1||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Clinical Trial Comparing Two Protocols Using IV Hydromorphone|
|Actual Study Start Date :||January 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
2 mg IV hydromorphone administered over 2-3 minutes as initial dose
2 mg IV hydromorphone
Other Name: Dilaudid
1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?"
1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Other Name: Dilaudid
- Number of Patients With Satisfactory Pain Management at 60 Minutes [ Time Frame: 60 minutes ]The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes. This is defined as the number of patients who declined additional pain medication at 60 minutes.
- Mean Change in Pain Intensity From Baseline to 60 Minutes [ Time Frame: 60 minutes ]Pain intensity is measured in numerical rating scale (NRS) units from 0 ("no pain") to 10 ("worst pain imaginable"). The change here represents the NRS score given by the patients at 60 minutes subtracted from the score at baseline, before treatment in the Emergency Department.
- Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes [ Time Frame: 60 minutes ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311895
|United States, New York|
|Montefiore Medical Center Moses Division Emergency Department|
|Bronx, New York, United States, 10467|