Trial Outcomes & Findings for The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA). (NCT NCT00273754)

Results Overview

The number of children having adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation \<95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the Operating Room and in the PACU was recorded.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

74 participants

Primary outcome timeframe

Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.

Results posted on

2016-06-16

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Normal Saline	Caffeine Caffeine benzoate
Overall Study STARTED	36	36
Overall Study COMPLETED	36	36
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=36 Participants Normal Saline	Caffeine n=36 Participants Caffeine benzoate	Total n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	5.3 years STANDARD_DEVIATION 2.9 • n=5 Participants	5.3 years STANDARD_DEVIATION 2.2 • n=7 Participants	5.3 years STANDARD_DEVIATION 2.5 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	36 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.

Population: The analysis was per protocol.

The number of children having adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation \<95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the Operating Room and in the PACU was recorded.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Normal Saline	Caffeine n=36 Participants Caffeine benzoate
Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.	21 Participants	11 Participants

SECONDARY outcome

Timeframe: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.

Population: Per protocol

The overall occurance of adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation \<95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the OR and in the PACU was noted.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Normal Saline	Caffeine n=36 Participants Caffeine benzoate
Occurence of Post Extubatory Respiratory Adverse Events.	34 Participants	17 Participants

SECONDARY outcome

Timeframe: Duration from anesthesia end until extubation time.

Time from end of anesthesia until extubation.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Normal Saline	Caffeine n=36 Participants Caffeine benzoate
Extubation Time.	11.3 minutes Standard Deviation 9.4	8.6 minutes Standard Deviation 4.9

SECONDARY outcome

Timeframe: Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.

A child with a Steward Recovery Scale score of 6 is defined as awake, coughing/crying, and has purposeful movements.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Normal Saline	Caffeine n=36 Participants Caffeine benzoate
Awakening Time	26.6 Minutes Standard Deviation 16.0	26.1 Minutes Standard Deviation 28.8

SECONDARY outcome

Timeframe: Time spent in PACU following surgical procedure prior to discharge home or hospital admission.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Normal Saline	Caffeine n=36 Participants Caffeine benzoate
Post Anesthesia Care Unit (PACU) Duration	74.4 minutes Standard Deviation 43.7	84.8 minutes Standard Deviation 44.1

SECONDARY outcome

Timeframe: Total time from end anesthesia to discharge home

Children were discharged from the hospital when they reached the hospital discharge criteria: they were awake, had stable vital signs, were breathing adequately, had O2 saturation \>95% while breathing room air, were able to swallow fluids, had no or minimal pain, and were able to ambulate without excessive nausea, vomiting, or dizziness.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Normal Saline	Caffeine n=36 Participants Caffeine benzoate
Hospital Discharge Time	107.0 Minutes Standard Deviation 54.5	98.2 Minutes Standard Deviation 55.9

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Caffeine

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

Samia Khalil, M.D./ Professor

University of Texas Medical School/ Houston

Phone: 713-500-6242

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place