Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage

Stopped early · Phase 2/Phase 3

Conditions studied: Headaches Associated With Subarachnoid Hemorrhage (SAH)

In brief

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.

Key facts

Study ID

NCT01851720

Run by

Johns Hopkins University

People needed

1

Starts

2012-07-01

Expected to finish

2014-09-15

Last updated by the study team

2017-06-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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