Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage

NCT ID: NCT01851720

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-09-15

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.

Conditions

Headaches Associated With Subarachnoid Hemorrhage (SAH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group / Standard of Care

• 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

Group Type: ACTIVE_COMPARATOR

Standard IV fentanyl bolus

Intervention Type: DRUG

Low dose IV 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

Group Type: ACTIVE_COMPARATOR

Low dose fentanyl PCA

Intervention Type: DRUG

Interventions

Low dose fentanyl PCA

Intervention Type: DRUG

Standard IV fentanyl bolus

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00071159

Identifier Type: -

Identifier Source: org_study_id