Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone

Acute Pain Clinical Trial

Official title:

Randomized Clinical Trial Comparing Two Protocols Using IV Hydromorphone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311895
• Other study ID #: MMC 10-07-201
• Status: Completed
• Phase: Phase 3
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: April 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• H2O
2 mg IV hydromorphone
• 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?"

Locations

Country	Name	City	State
United States	Montefiore Medical Center Moses Division Emergency Department	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Satisfactory Pain Management at 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.	60 minutes
Secondary	Mean Change in Pain Intensity From Baseline to 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.	60 minutes
Secondary	Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes		60 minutes