Trial Outcomes & Findings for A Prospective Observational Study of Epidural Pressures During Caudal Epidural in the Pediatric Population (NCT NCT02233309)

Results Overview

After administration of the single-shot bolus dose of the local anesthetic agent (1 mL/kg), the immediate post-bolus pressure was measured.

Recruitment status

COMPLETED

Target enrollment

36 participants

Primary outcome timeframe

Immediately post bolus

Results posted on

2015-05-28

Participant milestones
Measure	Monitoring of Pressures During Caudal Anesthesia Patients receiving caudal anesthesia as standard of care for a surgical procedure. Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study. Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol.
Overall Study STARTED	36
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	5

Reasons for withdrawal
Measure	Monitoring of Pressures During Caudal Anesthesia Patients receiving caudal anesthesia as standard of care for a surgical procedure. Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study. Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol.
Overall Study Physician Decision	5

A Prospective Observational Study of Epidural Pressures During Caudal Epidural in the Pediatric Population

Baseline characteristics by cohort
Measure	Monitoring of Pressures During Caudal Anesthesia n=36 Participants Patients receiving caudal anesthesia as standard of care for a surgical procedure. Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study. Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol.
Age, Categorical <=18 years	36 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	2.21 years STANDARD_DEVIATION 2.2 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	36 Participants n=99 Participants
Region of Enrollment United States	36 participants n=99 Participants

Timeframe: Immediately post bolus

Population: Due to errors in data collection or protocol violations, 5 patients were excluded leaving 31 patients for analysis.

After administration of the single-shot bolus dose of the local anesthetic agent (1 mL/kg), the immediate post-bolus pressure was measured.

Outcome measures
Measure	Monitoring of Pressures During Caudal Anesthesia n=31 Participants Patients receiving caudal anesthesia as standard of care for a surgical procedure. Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study. Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol.
Pressure in the Caudal Epidural Space	192.5 mmHg Standard Deviation 93.3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Nebraska Children's Hospital & Medical Center

Phone: (402) 955-4303