Trial Outcomes & Findings for The Use of Warmed Saline in Vaso-occlusive Episodes (NCT NCT02316366)

Results Overview

After being treated for pain in the Emergency Department, the disposition of the patient (whether admitted to the hospital for further care or discharge to home) was recorded.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

4 hours

Results posted on

2018-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Warm Fluid Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius	Room Temperature Fluid Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of Warmed Saline in Vaso-occlusive Episodes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Warm Fluid n=40 Participants Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius	Room Temperature Fluid n=40 Participants Patients receive intravenous saline at room temperature (22-24 degrees Celsius)	Total n=80 Participants Total of all reporting groups
Age, Continuous	14.3 years STANDARD_DEVIATION 4.7 • n=93 Participants	13.6 years STANDARD_DEVIATION 5.6 • n=4 Participants	14 years STANDARD_DEVIATION 5.1 • n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	23 Participants n=4 Participants	42 Participants n=27 Participants
Sex: Female, Male Male	21 Participants n=93 Participants	17 Participants n=4 Participants	38 Participants n=27 Participants
Region of Enrollment United States	40 participants n=93 Participants	40 participants n=4 Participants	80 participants n=27 Participants

PRIMARY outcome

Timeframe: 4 hours

After being treated for pain in the Emergency Department, the disposition of the patient (whether admitted to the hospital for further care or discharge to home) was recorded.

Outcome measures

Outcome measures
Measure	Warm Fluid n=40 Participants Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius	Room Temperature Fluid n=40 Participants Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
Rate of Hospital Admission	63 percentage of participants Interval 48.0 to 78.0	55 percentage of participants Interval 40.0 to 70.0

SECONDARY outcome

Timeframe: 4 hours

During the ED stay, patient's pain scores on the Wong-Baker FACES scale was recorded at 30 minute intervals until disposition decided. The difference between the pain score upon arrival and at discharge was assessed. Minimum value 1, maximum value 10 (most pain)

Outcome measures

Outcome measures
Measure	Warm Fluid n=40 Participants Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius	Room Temperature Fluid n=40 Participants Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
Difference in Pain Score	-2.6 units on a scale Standard Error 3.5	-2.9 units on a scale Standard Error 3.4

SECONDARY outcome

Timeframe: 4 hours

The amount of time spent in the ED was recorded for each patient

Outcome measures

Outcome measures
Measure	Warm Fluid n=40 Participants Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius	Room Temperature Fluid n=40 Participants Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
Time to Disposition	158 minutes Interval 140.0 to 175.0	155 minutes Interval 135.0 to 175.0

SECONDARY outcome

Timeframe: 4 hours

The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient

Outcome measures

Outcome measures
Measure	Warm Fluid n=40 Participants Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius	Room Temperature Fluid n=40 Participants Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
Amount of Narcotic Administered	0.31 mg/kg Interval 0.23 to 0.39	0.3 mg/kg Interval 0.23 to 0.38

SECONDARY outcome

Timeframe: 4 hours

Upon disposition patients were asked to complete a survey which assessed their global comfort during the ED stay. Question 2 of the survey addressed comfort by asking: "On a scale of 1 to 5, how do you think the fluid made you feel?" (1 is worse and 5 is better).

Outcome measures

Outcome measures
Measure	Warm Fluid n=29 Participants Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius	Room Temperature Fluid n=27 Participants Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
Global Comfort	4 units on a scale Interval 3.0 to 4.0	3 units on a scale Interval 3.0 to 5.0

Adverse Events

Warm Fluid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Room Temperature Fluid

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

Dr. Renee Quarrie, fellow

Nationwide Children's Hospital

Phone: 2037136871

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place