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NCT00825370 · ClinicalTrials.gov registry record · Phase 3

Protocolized vs Discretionary Use of Opioids in Acute Pain

A Phase 3 study of Pain, sponsored by Montefiore Medical Center.

Completed
Registry status
Phase 3
Development phase
350
Enrollment target
1
Study location

NCT00825370: Completed Phase 3 study of Pain, sponsored by Montefiore Medical Center.

NCT00825370 is a Phase 3 study of Pain that has completed, run by Montefiore Medical Center. The registered enrollment target is 350 participants, above the 303-participant average among 374 other Pain trials with a reported enrollment target (16% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00825370, a Phase 3 study of Pain, has completed, sponsored by Montefiore Medical Center.

COMPLETED
Registry status
Phase 3
Development phase
350 participants
Enrollment target
1
Study location

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.

Primary Outcome

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

Conditions Studied

Interventions

  • DRUG Hydromorphone
  • DRUG IV opioid

Study Locations (1)

New York

  • Montefiore Medical Center Emergency Department - The Bronx

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2008-10
Est. Completion 2009-05
Phase Phase 3
Montefiore Medical Center

345 total trials

What the finished NCT00825370 record still lists

NCT00825370 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, above the 303-participant average among 374 other Pain trials with a reported enrollment target (16% higher).

The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Hydromorphone is the first listed.

NCT00825370 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT00825370 about?

NCT00825370 is a clinical study titled "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...

What is the current status of trial NCT00825370?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2008-10. Estimated completion is 2009-05.

What conditions does trial NCT00825370 study?

This clinical trial studies the following conditions: Pain.

What interventions are being tested in trial NCT00825370?

The interventions under investigation include: Hydromorphone (DRUG), IV opioid (DRUG).

Who is sponsoring clinical trial NCT00825370?

This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00825370 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00825370's enrollment target sits among peer trials

350 52nd of 374 higher than 322 of 374 other Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00825370, the US trial registry maintained by the National Library of Medicine. NCT00825370 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.