Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage

Conditions
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Headaches Associated With Subarachnoid Hemorrhage (SAH)

Intervention / Treatment
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* Drug: Low dose fentanyl PCA
* Drug: Standard IV fentanyl bolus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group / Standard of Care<br>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<br> <br> |
| Active Comparator: Low dose IV fentanyl PCA<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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