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

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Postoperative Complications; Adenoidectomy; Sleep Apnea, Obstructive; Tonsillectomy

Treatments: Drug: Caffeine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00273754

HSC-MS-03-108

Details and patient eligibility

About

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).

Full description

Patients with OSA are reported to have a higher rate of severe respiratory complications associated with upper airway obstruction during anesthesia and sedation or immediately after anesthesia. Children with OSA (especially those under three years of age, those with severe OSA, cerebral palsy or craniofacial anomalies) are at increased risks for post-operative complications, and require careful monitoring post-operatively.

Although the etiology of obstructive sleep apnea is mainly obstruction due to anatomical and neuromuscular abnormalities, we believe that a central element may contribute to OSA.

The aim of this study is to evaluate whether administration of caffeine to children with OSA, scheduled for elective T & A under general anesthesia contributes to a faster recovery, less post-operative complications, and a shorter stay in the PACU, DSU and the hospital.

Enrollment: 74 patients

Sex: All

Ages: 30 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Saline

Treatment:

Drug: Placebo

Caffeine

Active Comparator group

Description:

Caffeine benzoate

Treatment:

Drug: Caffeine