Headaches Associated With Subarachnoid Hemorrhage (SAH) Clinical Trial
Official title:
Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage
| Verified date | June 2017 |
| Source | Johns Hopkins University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | September 15, 2014 |
| Est. primary completion date | September 15, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Johns Hopkins University | Baltimore | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Johns Hopkins University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |