Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage

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.

Study Overview

• Status: Terminated
• Conditions: Headaches Associated With Subarachnoid Hemorrhage (SAH)
• Intervention / Treatment: Drug: Standard IV fentanyl bolus; Drug: Low dose fentanyl PCA

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Standard IV fentanyl bolus
Active Comparator: 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	Drug: Low dose fentanyl PCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): September 15, 2014
• Study Completion (Actual): September 15, 2014

Study Registration Dates

• First Submitted: May 8, 2013
• First Submitted That Met QC Criteria: May 8, 2013
• First Posted (Estimate): May 10, 2013

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Intracranial Hemorrhages; Hemorrhage; Headache; Subarachnoid Hemorrhage; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: NA_00071159