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

Postoperative Complications Clinical Trial

— OSA  

Official title:

A Pilot Study to Evaluate if Caffeine Helps Children With Obstructive Sleep Apnea Recover Faster From Anesthesia, and With Less Complications After General Anesthesia for Tonsillectomy and Adenoidectomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273754
• Other study ID #: HSC-MS-03-108
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2006
• Last updated: December 11, 2015
• Start date: September 2003
• Est. completion date: May 2008

Study information

• Verified date: December 2015
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Months to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adenoidectomy
• Apnea
• Postoperative Complications
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Tonsillectomy

Intervention

Drug:
• Caffeine
Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base.
• Placebo
Children in group two will receive an amount of normal saline equal to Caffeine

Locations

Country	Name	City	State
United States	University of Texas, Health Science Center at Houston, Children's Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.	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.	Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.	Yes
Secondary	Occurence of Post Extubatory Respiratory Adverse Events.	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.	Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.	Yes
Secondary	Extubation Time.	Time from end of anesthesia until extubation.	Duration from anesthesia end until extubation time.	Yes
Secondary	Awakening Time	A child with a Steward Recovery Scale score of 6 is defined as awake, coughing/crying, and has purposeful movements.	Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.	Yes
Secondary	Post Anesthesia Care Unit (PACU) Duration		Time spent in PACU following surgical procedure prior to discharge home or hospital admission.	Yes
Secondary	Hospital Discharge Time	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.	Total time from end anesthesia to discharge home	Yes