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

This study has been completed.
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00273754
First received: January 4, 2006
Last updated: October 14, 2010
Last verified: October 2010

January 4, 2006
October 14, 2010
September 2003
May 2008   (final data collection date for primary outcome measure)
Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo. [ Time Frame: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room. ] [ Designated as safety issue: Yes ]
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.
  • - Complication in post operative care unit (PACU)
  • - Oxygen Saturation till patient reaches 6 on Steward Score
  • - Time after Anesthesia End to 6 on Steward Score
  • - Home complications
  • - Post-extubation complication in the operating room
Complete list of historical versions of study NCT00273754 on ClinicalTrials.gov Archive Site
  • Occurence of Post Extubatory Respiratory Adverse Events. [ Time Frame: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room. ] [ Designated as safety issue: Yes ]
    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.
  • Extubation Time. [ Time Frame: Duration from anesthesia end until extubation time. ] [ Designated as safety issue: Yes ]
    Time from end of anesthesia until extubation.
  • Awakening Time [ Time Frame: Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score. ] [ Designated as safety issue: Yes ]
    A child with a Steward Recovery Scale score of 6 is defined as awake, coughing/crying, and has purposeful movements.
  • Post Anesthesia Care Unit (PACU) Duration [ Time Frame: Time spent in PACU following surgical procedure prior to discharge home or hospital admission. ] [ Designated as safety issue: Yes ]
  • Hospital Discharge Time [ Time Frame: Total time from end anesthesia to discharge home ] [ Designated as safety issue: Yes ]
    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.
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The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).
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.

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Sleep Apnea, Obstructive
  • Tonsillectomy
  • Adenoidectomy
  • Postoperative Complications
  • 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.
    Other Name: Caffeine
  • Drug: Placebo
    Children in group two will receive an amount of normal saline equal to Caffeine
    Other Name: Saline
  • Placebo Comparator: Placebo
    Saline
    Intervention: Drug: Placebo
  • Active Comparator: Caffeine
    Caffeine benzoate
    Intervention: Drug: Caffeine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
30 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00273754
HSC-MS-03-108
No
Samia Khalil, M.D., University of Texas Medical School, Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Samia N. Khalil, MD The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP