Trial Outcomes & Findings for Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage (NCT NCT01851720)

NCT ID: NCT01851720

Last Updated: 2017-06-22

Results Overview

Pain score 0-10. 0 represented no pain and 10 worst pain

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 1 participants
• Primary outcome timeframe: 4 days
• Results posted on: 2017-06-22

Participant Flow

Participant milestones

Measure	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 Standard IV fentanyl bolus	Low Dose IV Fentanyl Patient Controlled Analgesia (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 Low dose fentanyl PCA
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	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 Standard IV fentanyl bolus	Low Dose IV Fentanyl Patient Controlled Analgesia (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 Low dose fentanyl PCA
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage

Baseline characteristics by cohort

Measure	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 Standard IV fentanyl bolus	Low Dose IV Fentanyl PCA n=1 Participants * 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 Low dose fentanyl PCA	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	—	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 days

Population: Though one subject in the PCA arm completed enrollment, we had insufficient data to perform any comparative analysis. We do no intend to summarize the patient's results.

Pain score 0-10. 0 represented no pain and 10 worst pain

Outcome measures

Measure	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 Standard IV fentanyl bolus	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 Low dose fentanyl PCA
Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS).	0	0

Adverse Events

Control Group / Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Dose IV Fentanyl PCA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alex Coon

Johns Hopkins School of Medicine

Phone: 410-955-2438

Email: acoon2@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place