Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage

Phase 2

Terminated

Conditions: Headaches Associated With Subarachnoid Hemorrhage (SAH)

Interventions: Drug: Standard IV fentanyl bolus
Drug: Low dose fentanyl PCA

Registration Number: NCT01851720

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group / Standard of Care	Standard IV fentanyl bolus	* 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
Low dose IV fentanyl PCA	Low dose 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

Primary Outcome Measures

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

Secondary Outcome Measures