Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01851720
Recruitment Status : Terminated (Inclusion criteria were too strict and therefore we were not able to recruit more patients.)
First Posted : May 10, 2013
Results First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment Phase
Headaches Associated With Subarachnoid Hemorrhage (SAH) Drug: Low dose fentanyl PCA Drug: Standard IV fentanyl bolus Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage
Study Start Date : July 2012
Primary Completion Date : September 15, 2014
Study Completion Date : September 15, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Headache
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Control group / Standard of Care
  • IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain
  • (Bolus dose can be titrated up in 25 mcg increments if necessary)
  • Maximum dose of 100 mcg/hr
Drug: Standard IV fentanyl bolus
Active Comparator: Low dose IV fentanyl PCA
  • Initially: 10 mcg demand dose every 12 minutes
  • No initial bolus and no continuous infusion
  • Demand dose increased 10 mcg every 12 minutes if necessary
  • Maximum dose of 100 mcg/hr
Drug: Low dose fentanyl PCA

Primary Outcome Measures :
  1. Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS). [ Time Frame: 4 days ]
    Pain score 0-10. 0 represented no pain and 10 worst pain

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age>18-75
  • Glasgow Coma Scale (GCS) 13 or greater
  • Hunt and Hess grade I, II conditions
  • Admitted within 2 days of initial SAH event >6/10 pain on presentation

Exclusion Criteria:

  • Aphasia
  • Head trauma within the past 30 days
  • Need for craniotomy
  • h/o obstructive sleep apnea or respiratory disease
  • h/o opioid tolerance
  • evidence of vasospasm
  • h/o liver disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01851720

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University

Responsible Party: Johns Hopkins University Identifier: NCT01851720     History of Changes
Other Study ID Numbers: NA_00071159
First Posted: May 10, 2013    Key Record Dates
Results First Posted: June 22, 2017
Last Update Posted: June 22, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Subarachnoid Hemorrhage
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General