Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage
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ClinicalTrials.gov Identifier: NCT01851720
Recruitment Status :
(Inclusion criteria were too strict and therefore we were not able to recruit more patients.)
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
Headaches Associated With Subarachnoid Hemorrhage (SAH)
Drug: Low dose fentanyl PCADrug: Standard IV fentanyl bolus
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Head trauma within the past 30 days
Need for craniotomy
h/o obstructive sleep apnea or respiratory disease
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents