Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone

Condition(s) targeted: Acute Pain

Intervention: H2O (Drug); 1+1 (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Montefiore Medical Center

Overall contact:
Andrew Chang, MD, MS, Phone: 718-920-6626, Email: achang3@yahoo.com

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.

Official title: Randomized Clinical Trial Comparing Two Protocols Using IV Hydromorphone

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Decline additional pain medication

Secondary outcome:

Number of participants with hypotension (SBP < 90 mmHg)

Number of participants with bradycardia (HR < 50/min)

Number of patients with nausea and vomiting

Number of participants with pruritus

Number of participants needing naloxone as a reversal agent

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

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 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 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. SBP <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 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. C02 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 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

Andrew Chang, MD, MS, Phone: 718-920-6626, Email: achang3@yahoo.com

Montefiore Medical Center Moses Division Emergency Department, Bronx, New York 10467, United States; Recruiting
Andrew Chang, MD, MS, Phone: 718-920-6626, Email: achang3@yahoo.com
Andrew K Chang, MD, MS, Principal Investigator

Starting date: January 2010
Last updated: September 15, 2011