Trial Outcomes & Findings for Intravenous Fluids in Benign Headaches Trial (NCT NCT03185130)

NCT ID: NCT03185130

Last Updated: 2024-06-06

Results Overview

The primary outcome measure will be the mean reduction in pain scores at 60 min. In other words the pain score at time zero minus the pain score at time 60 minutes. Pain scores are measured 0-100, with 0 being no pain and 100 being maximal pain, on a visual analog scale score. Higher numbers indicate more pain reduction.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 58 participants
• Primary outcome timeframe: 60 minutes
• Results posted on: 2024-06-06

Participant Flow

Participant milestones

Measure	Standard Treatment Arm Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 5mL: Control arm subjects will receive Normal Saline 5 mL IV over 1 hour Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push	Study Arm Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 20mL/kg: Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour, Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Overall Study STARTED	23	35
Overall Study COMPLETED	23	33
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Standard Treatment Arm Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 5mL: Control arm subjects will receive Normal Saline 5 mL IV over 1 hour Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push	Study Arm Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 20mL/kg: Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour, Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Intravenous Fluids in Benign Headaches Trial

Baseline characteristics by cohort

Measure	Standard Treatment Arm n=23 Participants Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 5mL: Control arm subjects will receive Normal Saline 5 mL IV over 1 hour Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push	Study Arm n=35 Participants Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 20mL/kg: Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour, Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push	Total n=58 Participants Total of all reporting groups
Age, Continuous	31.7 years STANDARD_DEVIATION 14.7 • n=93 Participants	32.3 years STANDARD_DEVIATION 14.1 • n=4 Participants	32.0 years STANDARD_DEVIATION 14.2 • n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	20 Participants n=4 Participants	37 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	15 Participants n=4 Participants	21 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants	12 Participants n=4 Participants	17 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=93 Participants	23 Participants n=4 Participants	41 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	23 participants n=93 Participants	35 participants n=4 Participants	58 participants n=27 Participants

PRIMARY outcome

Timeframe: 60 minutes

The primary outcome measure will be the mean reduction in pain scores at 60 min. In other words the pain score at time zero minus the pain score at time 60 minutes. Pain scores are measured 0-100, with 0 being no pain and 100 being maximal pain, on a visual analog scale score. Higher numbers indicate more pain reduction.

Outcome measures

Measure	Standard Treatment Arm n=23 Participants Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 5mL: Control arm subjects will receive Normal Saline 5 mL IV over 1 hour Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push	Study Arm n=33 Participants Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 20mL/kg: Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour, Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Reduction in Pain Scores at 60 Minutes	48.7 reduction in visual analog pain score Standard Deviation 29.3	48.3 reduction in visual analog pain score Standard Deviation 31.0

SECONDARY outcome

Timeframe: 30 minutes

The mean reduction in pain scores at 30 minutes. This is calculated as the pain score at time zero minus the pain score at time 30 minutes. Pain scores are measured 0-100 on a visual analog scale score, with 0 being no pain and 100 being maximal pain. Higher numbers indicate more pain reduction.

Outcome measures

Measure	Standard Treatment Arm n=23 Participants Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 5mL: Control arm subjects will receive Normal Saline 5 mL IV over 1 hour Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push	Study Arm n=35 Participants Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 20mL/kg: Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour, Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Reduction in Pain Score at 30 Minutes	34.8 change in pain score Standard Deviation 29.6	31.8 change in pain score Standard Deviation 27.1

SECONDARY outcome

Timeframe: 1 day

The difference between the rates of admission will be measured.

Outcome measures

Measure	Standard Treatment Arm n=23 Participants Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 5mL: Control arm subjects will receive Normal Saline 5 mL IV over 1 hour Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push	Study Arm n=35 Participants Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 20mL/kg: Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour, Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Admissions	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 60 minutes

The reduction in mean nausea scores will be measured. This is calculated as the nausea score at time zero minus the nausea score at time 60 minutes. Nausea is measured from 0-100 on a visual analog scale with 0 being no nausea and 100 being maximal nausea. Higher numbers indicate more reduction in nausea.

Outcome measures

Measure	Standard Treatment Arm n=23 Participants Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 5mL: Control arm subjects will receive Normal Saline 5 mL IV over 1 hour Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push	Study Arm n=33 Participants Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 20mL/kg: Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour, Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Reduction in Nausea Score at 60 Minutes	31.8 reduction in nausea score Standard Deviation 33.4	25.2 reduction in nausea score Standard Deviation 34.2

SECONDARY outcome

Timeframe: 60 minutes

The difference in the percentage of patients in each group who vomit within one hour after the treatment starts.

Outcome measures

Measure	Standard Treatment Arm n=23 Participants Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 5mL: Control arm subjects will receive Normal Saline 5 mL IV over 1 hour Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push	Study Arm n=33 Participants Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 20mL/kg: Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour, Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Vomiting	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 60 minutes

The difference between the percentage of patients requiring rescue medications for headache will be measured. "Rescue medications" are defined as any medication administered to the patient in the emergency department for their headache after the initial medications.

Outcome measures

Measure	Standard Treatment Arm n=23 Participants Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 5mL: Control arm subjects will receive Normal Saline 5 mL IV over 1 hour Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push	Study Arm n=35 Participants Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 20mL/kg: Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour, Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Rescue Medication	3 Participants	7 Participants

SECONDARY outcome

Timeframe: 24-48 hours after discharge.

The difference between the rates of persistent headache with telephone follow up.

Outcome measures

Measure	Standard Treatment Arm n=17 Participants Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 5mL: Control arm subjects will receive Normal Saline 5 mL IV over 1 hour Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push	Study Arm n=27 Participants Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV. Normal Saline 20mL/kg: Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour, Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Percentage of Patients With Persistent Headache	4 Participants	11 Participants

Adverse Events

Standard Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Study Arm

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

Tony Zitek, MD

University Medical Center of Southern Nevada

Phone: 7023837885

Email: zitek10@gmail.com

Results disclosure agreements

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