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NCT01851720 · ClinicalTrials.gov registry record · Phase 2

Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage

A Phase 2 study, sponsored by Johns Hopkins University.

Terminated
Registry status
Phase 2
Development phase
1
Enrollment target

NCT01851720: Clinical Trial Phase 2 study, sponsored by Johns Hopkins University.

NCT01851720 is a Phase 2 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01851720, a Phase 2 study, was terminated before completion, sponsored by Johns Hopkins University.

TERMINATED
Registry status
Phase 2
Development phase
1 participants
Enrollment target

Study Summary

Headaches associated with subarachnoid hemorrhage (SAH) cause severe pain. Headache management is complex, requiring a balance between pain control and preservation of neurological assessment. Sufficient pain control can be achieved with narcotics, however, these carry numerous undesirable side effects. Most critically, all narcotics can result in respiratory depression and sedation. For patients who present without neurological defects but debilitating pain, management is particularly challenging. The sedative effect of narcotics confounds the management of these patients by interfering with the neurological examination. Pain management is also a significant concern for patient's families as they observe suffering without full understanding of the importance of preserved mental status. In order to control the pain associated with SAH headaches, the use of narcotics is often required despite the risks. This standard therapy involves an IV bolus dose delivered by the provider regularly as needed for pain control. A common approach to reduce pain in other patient populations, including acute pain relief following major spine surgery, is patient controlled analgesia (PCA). With the PCA method, patients deliver low doses of narcotics through a pain pump with preset maximal doses and frequency of delivery. We hypothesize that this approach to pain relief for SAH headaches will result in lower pain scores, greater patient and family satisfaction scores, and increased patient safety with lower narcotic doses minimally interfering with neurological assessment.

Primary Outcome

Pain score 0-10. 0 represented no pain and 10 worst pain

Interventions

  • DRUG Low dose fentanyl PCA
  • DRUG Standard IV fentanyl bolus

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2012-07
Est. Completion 2014-09-15
Phase Phase 2
Johns Hopkins University

1,448 total trials

Why NCT01851720 stopped before completion

NCT01851720 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Low dose fentanyl PCA is the first listed.

NCT01851720 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01851720 about?

NCT01851720 is a clinical study titled "Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage". Headaches associated with subarachnoid hemorrhage (SAH) cause severe pain. Headache management is complex, requiring a balance between pain control and preservation of neurological assessment. Sufficient pain control can be achieved with narcotics, however, these carry numerous undesirable side effe...

What is the current status of trial NCT01851720?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2012-07. Estimated completion is 2014-09-15.

What interventions are being tested in trial NCT01851720?

The interventions under investigation include: Low dose fentanyl PCA (DRUG), Standard IV fentanyl bolus (DRUG).

Who is sponsoring clinical trial NCT01851720?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01851720's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01851720, the US trial registry maintained by the National Library of Medicine. NCT01851720 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.