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Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage

Primary Purpose

Headaches Associated With Subarachnoid Hemorrhage (SAH)

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Low dose fentanyl PCA
Standard IV fentanyl bolus
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headaches Associated With Subarachnoid Hemorrhage (SAH)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group / Standard of Care

Low dose IV fentanyl PCA

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 8, 2013
Last Updated
June 20, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01851720
Brief Title
Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage
Official Title
Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Inclusion criteria were too strict and therefore we were not able to recruit more patients.
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 15, 2014 (Actual)
Study Completion Date
September 15, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headaches Associated With Subarachnoid Hemorrhage (SAH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group / Standard of Care
Arm Type
Active Comparator
Arm Description
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
Arm Title
Low dose IV fentanyl PCA
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Low dose fentanyl PCA
Intervention Type
Drug
Intervention Name(s)
Standard IV fentanyl bolus
Primary Outcome Measure Information:
Title
Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS).
Description
Pain score 0-10. 0 represented no pain and 10 worst pain
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage

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