Headaches Associated With Subarachnoid Hemorrhage (SAH)Phase 2/3NCT01851720
Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage
A Phase 2/3 study testing Low dose fentanyl PCA and Standard IV fentanyl bolus in people with Headaches Associated With Subarachnoid Hemorrhage (SAH), run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Headaches Associated With Subarachnoid Hemorrhage (SAH)
- What is being tested?
- Low dose fentanyl PCA and Standard IV fentanyl bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 15 Sep 2014
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Low dose fentanyl PCA, Standard IV fentanyl bolus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose fentanyl PCADrug
Standard IV fentanyl bolusDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Low dose fentanyl PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startJul 2012
- Primary completion15 Sep 2014
- Study completion15 Sep 2014
Why it stopped: Inclusion criteria were too strict and therefore we were not able to recruit more patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Headaches Associated With Subarachnoid Hemorrhage (SAH)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851720
- Sponsor's protocol ID
- NA_00071159
- Status last verified
- Jun 2017
- First submitted
- 8 May 2013
- Last updated
- 22 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01851720
- Acronym / sponsor ID
- NA_00071159
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion criteria were too strict and therefore we were not able to recruit more patients.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- 15 Sep 2014 (actual)
- Study completion
- 15 Sep 2014 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Posted 22 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group / Standard of Care | Active comparator | Drug: 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 | Active comparator | Drug: 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Aphasia
- Head trauma within the past 30 days
- Need for craniotomy
- h/o obstructive sleep apnea or respiratory disease
- h/o opioid tolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose fentanyl PCA | Drug | Low dose IV fentanyl PCA |
| Standard IV fentanyl bolus | Drug | Control group / Standard of Care |
Primary outcome
Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS).
Time frame: 4 days
Pain score 0-10. 0 represented no pain and 10 worst pain
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Low dose fentanyl PCA and Standard IV fentanyl bolus in people with Headaches Associated With Subarachnoid Hemorrhage (SAH), run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS). (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017; AzTrials last refreshed its copy on 6 Nov 2026.