Phase 2
Completed N=72
The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).
Sleep Apnea, Obstructive · tonsillectomy · Adenoidectomy · Postoperative Complications
Source: ClinicalTrials.gov NCT00273754 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Nov 2010
Primary outcomePrimary: Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo. — 21; 11 Participants
Summary
This is a research study using caffeine in children who have an obstructive sleep apnea (OSA). OSA means children who stop breathing during their sleep due to obstruction in their airway. The purpose of this study is to determine whether caffeine when given in the vein, will wake children up faster and decrease post-anesthesia airway obstruction, as well as the safety and if the drug agrees with the child compared to a placebo (an inactive or dummy agent).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo. |
21; 11 | — |
| SECONDARY Occurence of Post Extubatory Respiratory Adverse Events. |
34; 17 | — |
| SECONDARY Extubation Time. |
11.3; 8.6 | — |
| SECONDARY Awakening Time |
26.6; 26.1 | — |
| SECONDARY Post Anesthesia Care Unit (PACU) Duration |
74.4; 84.8 | — |
| SECONDARY Hospital Discharge Time |
107.0; 98.2 | — |
Eligibility Criteria
Inclusion Criteria
- Children between 2.5-18 years old
- Diagnosed with obstructive sleep apnea
- Undergoing elective tonsillectomy and adenoidectomy
Exclusion Criteria
- Age below 2.5 or above 18 years
Data sourced from ClinicalTrials.gov (NCT00273754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.