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
• Sponsor: Montefiore Medical Center
• Information provided by (Responsible Party): Andrew Chang, MD, Montefiore Medical Center

Study Description

Brief Summary:

The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the treatment of acute severe pain in the emergency department. The investigators primary hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in Emergency Department patients aged 21-64 years. The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes.

Condition or disease	Intervention/treatment	Phase
Acute Pain	Drug: H2O; Drug: 1+1	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: H2O; 2 mg IV hydromorphone administered over 2-3 minutes as initial dose	Drug: H2O; 2 mg IV hydromorphone; Other Name: Dilaudid
Experimental: 1+1; 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?"	Drug: 1+1; 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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes [ Time Frame: 60 minutes ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age greater than 21 years and less than 65 years: This is a study of non-elderly adult patients. In addition, patients aged 21 years and younger are automatically triaged to the Children's Emergency Department (ED).
2. Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature.
3. ED attending physician's judgment that patient's pain warrants intravenous (IV) opioids

Exclusion Criteria:

1. Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
2. Prior adverse reaction to opioids.
3. Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
4. Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
5. Systolic Blood Pressure <90 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
6. Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
7. Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.

8. CO2 measurement greater than 46: In accordance with standard protocol, three subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46 then the patient will be excluded from the study. The 3 subsets are as follows:

   • All patients who have a history of chronic obstructive pulmonary disease (COPD)
   • All patients who report a history of asthma together with greater than a 20 pack-year smoking history
   • All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation

Contacts and Locations

Locations

United States, New York

Montefiore Medical Center Moses Division Emergency Department

Bronx, New York, United States, 10467

Sponsors and Collaborators

Montefiore Medical Center

More Information

• Responsible Party: Andrew Chang, MD, Professor, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT01311895
• Other Study ID Numbers: MMC 10-07-201
• First Posted: March 10, 2011
• Results First Posted: May 18, 2018
• Last Update Posted: May 18, 2018
• Last Verified: April 2018

Keywords provided by Andrew Chang, MD, Montefiore Medical Center:

acute; pain; emergency department; hydromorphone

Additional relevant MeSH terms:

Acute Pain; Pain; Neurologic Manifestations; Hydromorphone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents