Trial Outcomes & Findings for Cortisol Response to Moderate and Deep Sedation in Children (NCT NCT01265966)

Results Overview

Salivary cortisol will be measured prior to the sedated procedure before any intravenous lines or other stress occurs, and then every 30 minutes into the sedated procedure while the patient is being routinely suctioned. Salivary cortisol will also be measured at the end of the procedure and 30 minutes post procedure (recovery). Because many different types of procedures are performed (imaging, endoscopy, surgical) the end times of the procedures will vary for each patient. The investigators will calculate a relative change from baseline for salivary cortisol levels by comparing the peak to baseline recorded level.

Recruitment status

COMPLETED

Target enrollment

149 participants

Primary outcome timeframe

Baseline, then every 30 minutes, and at end of procedure

Results posted on

2013-03-11

Participant Flow

All patients were recruited over a 7 month period from the Tripler Army Medical Center Pediatric Sedation Center.

149 patients were recruited. 117 had samples adequate for analysis. 7 patients were on inhaled and/or intranasal steroids, and were analyzed separately. Therefore 110 were included in the main analysis.

Participant milestones

Participant milestones
Measure	Moderate Sedation Children undergoing moderate sedation for procedures.	Deep Sedation Children undergoing deep sedation for procedures.	General Anesthesia Children undergoing general anesthesia for procedures.
Overall Study STARTED	47	41	29
Overall Study Analyzed Separately	3	2	2
Overall Study COMPLETED	44	39	27
Overall Study NOT COMPLETED	3	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cortisol Response to Moderate and Deep Sedation in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moderate Sedation n=47 Participants Children undergoing moderate sedation for procedures.	Deep Sedation n=41 Participants Children undergoing deep sedation for procedures.	General Anesthesia n=29 Participants Children undergoing general anesthesia for procedures.	Total n=117 Participants Total of all reporting groups
Age, Categorical <=18 years	47 Participants n=5 Participants	41 Participants n=7 Participants	29 Participants n=5 Participants	117 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants	59 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	25 Participants n=7 Participants	13 Participants n=5 Participants	58 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, then every 30 minutes, and at end of procedure

Population: All patients with adequate samples for analysis.

Salivary cortisol will be measured prior to the sedated procedure before any intravenous lines or other stress occurs, and then every 30 minutes into the sedated procedure while the patient is being routinely suctioned. Salivary cortisol will also be measured at the end of the procedure and 30 minutes post procedure (recovery). Because many different types of procedures are performed (imaging, endoscopy, surgical) the end times of the procedures will vary for each patient. The investigators will calculate a relative change from baseline for salivary cortisol levels by comparing the peak to baseline recorded level.

Outcome measures

Outcome measures
Measure	Moderate Sedation n=44 Participants Children undergoing moderate sedation for procedures.	Deep Sedation n=39 Participants Children undergoing deep sedation for procedures.	General Anesthesia n=27 Participants Children undergoing general anesthesia for procedures.
Change From Baseline to Peak Salivary Cortisol Level	2.9 Number (ratio of peak to baseline) Standard Error .2	4.3 Number (ratio of peak to baseline) Standard Error 0.8	3.3 Number (ratio of peak to baseline) Standard Error 1.0

Adverse Events

Moderate Sedation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Deep Sedation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

General Anesthesia

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. Jordan Pinsker

Tripler Army Medical Center

Phone: 808-433-6338

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place