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OpenTrials
Completed

NCT Number: NCT00825370

Protocolized vs Discretionary Use of Opioids in Acute Pain

We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the patients receives whatever IV opioid the treating physician wants to give, in whatever dose.

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Key information

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Montefiore Medical Center Emergency Department

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 21 to 64 years.
  • Pain with onset within 7 days.
  • Emergency Department attending physician's judgment that patient's pain warrants use of intravenous opioids.
  • Normal mental status.

Exclusion criteria

  • Prior use of methadone.
  • Use of other opioids, tramadol, or heroin in the past seven days.
  • Prior adverse reaction to morphine, hydromorphone, or other opioids.
  • Chronic pain syndrome.
  • Alcohol intoxication.
  • Systolic Blood Pressure < 90 mm Hg.
  • Use of monoamine oxidase (MAO) inhibitors in past 30 days.
  • Weight less than 100 pounds.
  • Baseline room air oxygen saturation less than 95%.
  • C02 measurement greater than 46: In accordance with a number of similar studies that we have performed, four 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 4 subsets are as follows:
  • All patients who have a history of chronic obstructive pulmonary disease (COPD)
  • All patients who have a history of sleep apnea
  • 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

Hydromorphone

Drug

1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later

Other names: Dilaudid

IV opioid

Drug

Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.

Other names: Discretionary care

Primary outcomes

  1. Percentage of Patients With Successful Treatment

    Time frame: 60 minutes

    Successful treatment was defined as either declining additional pain medication when asked at 15 minutes or accepting additional pain medication at 15 minutes but then declining additional pain medication at 60 minutes

Secondary outcomes

  1. Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes

    Time frame: 15 min

    As defined by the percentage of patients who answer "no" to the question, "Do you want more pain medication?" at 15 minutes

  2. Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes

    Time frame: 60 minutes

    Patients who did not want pain medication determined by those who answered "no" to the question "do you want more pain medication?" at 60 minutes after treatment.

  3. Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).

    Time frame: Up to 60 minutes

    Mean change in pain intensity between baseline and 15 minutes and between baseline and 60 minutes post treatment. Pain intensity is measured on a numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable"). The averages were calculated by finding the mean of change in pain intensity for each patient.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 21, 2009
Registry last updated
Jun 12, 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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