Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage

NCT01851720 | Terminated Phase 2 Results

• 1 other identifier: NA_00071159
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control group / Standard of Care

ACTIVE COMPARATOR

* 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

Low dose IV fentanyl PCA

ACTIVE COMPARATOR

* 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

Interventions

Low dose fentanyl PCA DRUG

Low dose IV fentanyl PCA

Standard IV fentanyl bolus DRUG

Control group / Standard of Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Results Point of Contact

• Title: Alex Coon
• Organization: Johns Hopkins School of Medicine

acoon2@jhmi.edu

410-955-2438

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 10, 2013
• Study Start: July 1, 2012
• Primary Completion: September 15, 2014
• Study Completion: September 15, 2014
• Last Updated: June 22, 2017
• Results First Posted: June 22, 2017

Record last verified: 2017-06

Locations

US (1)