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CompletedNCT00825370Updated Jun 12, 2018Results posted

Protocolized vs Discretionary Use of Opioids in Acute Pain

A Phase 3 interventional study of Hydromorphone and IV opioid in Pain, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-12.

Sponsored by Montefiore Medical Center · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Oct 2008, registered Jan 2009).
Phase
Phase 3
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
21 Years to 64 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pain

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Keywords

  • Hydromorphone
  • acute pain
  • Protocolized
  • Efficacy
  • Safety
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 350 is above the median of 70 across 2,101 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Montefiore Medical Center is the lead sponsor of 414 studies on the registry; 69 are open to participants now.

Of its 86 completed or terminated interventional studies of FDA-regulated products, 76 (88%) have results posted.

Browse Montefiore Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Prior use of methadone.
  2. Use of other opioids, tramadol, or heroin in the past seven days.
  3. Prior adverse reaction to morphine, hydromorphone, or other opioids.
  4. Chronic pain syndrome.
  5. Alcohol intoxication.
  6. Systolic Blood Pressure \< 90 mm Hg.
  7. Use of monoamine oxidase (MAO) inhibitors in past 30 days.
  8. Weight less than 100 pounds.
  9. Baseline room air oxygen saturation less than 95%.

  10. 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:

    1. All patients who have a history of chronic obstructive pulmonary disease (COPD)
    2. All patients who have a history of sleep apnea
    3. All patients who report a history of asthma together with greater than a 20 pack-year smoking history
    4. All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
350 participants (actual)

Study arms

  • Experimental
    Protocolized

    1 mg IV 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?"

    Drug: Hydromorphone

  • Active comparator
    Discretionary Care

    Patients receive an IV opioid the type and dose of which is determined by the treating physician

    Drug: IV opioid

Interventions

  • DrugHydromorphone

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

    Also known as: Dilaudid

  • DrugIV opioid

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

    Also known as: Discretionary care

06

What researchers measure

Primary outcomes

  1. Percentage of Patients With Successful Treatment

    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

    Time frame: 60 minutes

Secondary outcomes

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

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

    Time frame: 15 min

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

    Time frame: 60 minutes

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

    Time frame: Up to 60 minutes

07

Results

Posted Apr 19, 2018

Participant flow

Participant flow — Overall Study
MilestoneProtocolizedDiscretionary Care
Started175175
Completed175175
Not completed00

Outcome measures

PrimaryPercentage of Patients With Successful Treatment

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

Time frame:
60 minutes
Reported as:
Number · Percentage of Participants
Percentage of Patients With Successful Treatment
Percentage of ParticipantsProtocolizedDiscretionary Care
Percentage of Patients With Successful Treatment86.876.6
SecondaryPercentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes

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

Time frame:
15 min
Reported as:
Number · Percentage of Participants
Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes
Percentage of ParticipantsProtocolizedDiscretionary Care
Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes73.766.7
SecondaryPercentage of Patients Who Did Not Want Additional Pain Medication at 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.

Time frame:
60 minutes
Reported as:
Number · percentage of participants
Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes
percentage of participantsProtocolizedDiscretionary Care
Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes72.563.7
SecondaryChanges in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 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.

Time frame:
Up to 60 minutes
Reported as:
Mean · units on a scale
Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).
units on a scaleProtocolizedDiscretionary Care
15 minutes4.90 ± 3.14.55 ± 3.0
60 minutes5.32 ± 3.14.66 ± 3.1

Adverse events

Collected over 60 minutes. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Protocolized0/167 (0%)0/167 (0%)22/167 (13.2%)
Discretionary Care0/171 (0%)0/171 (0%)30/171 (17.5%)
Most frequent other events
Most frequent other events
EventProtocolizedDiscretionary Care
NauseaGastrointestinal disorders5/8215/102
VomitingGastrointestinal disorders8/1205/125
PruritusSkin and subcutaneous tissue disorders5/1674/171
Systolic blood pressure <90 mmHgVascular disorders3/1672/171
Oxygen saturation <95%Respiratory, thoracic and mediastinal disorders1/1672/171
Respiratory rate <12 breaths/minRespiratory, thoracic and mediastinal disorders0/1672/171
Administration of NaloxoneEndocrine disorders0/1670/171

Baseline characteristics

The discrepancy between the number of patients who completed the study and the number of patients included in analysis is due to missing data (6 Protocolized and 4 Discretionary) and participants enrolled more than once (2 Protocolized). These patients completed the study but had duplicate or missing data that could not be included in analysis.

Age, Continuous
Age, Continuous(years)ProtocolizedDiscretionary CareTotal
Mean42 ± 1142 ± 1342 ± 12
Sex: Female, Male
Sex: Female, Male(Participants)ProtocolizedDiscretionary CareTotal
Female10798205
Male6073133
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)ProtocolizedDiscretionary CareTotal
Race/Ethnicity — Hispanic110114224
Race/Ethnicity — Black474390
Race/Ethnicity — White7916
Race/Ethnicity — Other358
Region of Enrollment
Region of Enrollment(Participants)ProtocolizedDiscretionary CareTotal
United States167171338
Weight
Weight(pounds)ProtocolizedDiscretionary CareTotal
Mean185 ± 52173 ± 44179 ± 48
Location of pain
Location of pain(Participants)ProtocolizedDiscretionary CareTotal
Abdomen11395208
Other5476130
Pain Intensity
Pain Intensity(Participants)ProtocolizedDiscretionary CareTotal
3-7222446
8223254
9252449
109891189
Nausea
Nausea(Participants)ProtocolizedDiscretionary CareTotal
Count of participants6244106

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Montefiore Medical Center Emergency Department
    The Bronx, New York 10467, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00825370
Lead sponsor
Montefiore Medical Center
Responsible party
Andrew Chang, MD (MD, Montefiore Medical Center) — Principal investigator
First posted
Jan 21, 2009
Start date
Oct 2008
Primary completion
May 2009
Completion
May 2009
Results posted
Apr 19, 2018
Last update
Jun 12, 2018

Study contacts

Andrew K Chang, MD
principal investigator · Montefiore Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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