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Completed

NCT Number: NCT01311895

Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone

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.

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Key information

Conditions

Acute Pain Disease Attributes Emergencies Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Montefiore Medical Center Moses Division Emergency Department

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature.
  • ED attending physician's judgment that patient's pain warrants intravenous (IV) opioids

Exclusion criteria

  • 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.
  • Prior adverse reaction to opioids.
  • 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.
  • Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
  • Systolic Blood Pressure <90 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
  • Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
  • 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.
  • 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

Treatment and study plan

H2O

Drug

2 mg IV hydromorphone

Other names: Dilaudid

1+1

Drug

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 names: Dilaudid

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Randomized Clinical Trial Comparing Two Protocols Using IV Hydromorphone

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 10, 2011
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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