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Completed

NCT Number: NCT00273754

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

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).

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Key information

Conditions

Sleep Apnea, Obstructive Adenoidectomy Apnea Dyssomnias Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Tonsillectomy

Age range

30 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas, Health Science Center at Houston, Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine

Drug

Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base.

Placebo

Drug

Children in group two will receive an amount of normal saline equal to Caffeine

Other names: Saline

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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.

    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.

  2. Extubation Time.

    Time frame: Duration from anesthesia end until extubation time.

    Time from end of anesthesia until extubation.

  3. Awakening Time

    Time frame: 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.

  4. Post Anesthesia Care Unit (PACU) Duration

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

  5. Hospital Discharge Time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study 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.

Acronym: OSA

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jan 9, 2006
Registry last updated
Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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