NCT00273754

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

November 10, 2010

Completed
Last Updated

June 16, 2016

Status Verified

May 1, 2016

Enrollment Period

4.7 years

First QC Date

January 4, 2006

Results QC Date

June 5, 2009

Last Update Submit

May 12, 2016

Conditions

Sleep Apnea, ObstructiveTonsillectomyAdenoidectomyPostoperative Complications

Keywords

Obstructive Sleep Apnea (OSA)Tonsillectomy and Adenoidectomy (T&A)Postoperative ComplicationsRecovery

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (5)

  • Occurence of Post Extubatory Respiratory Adverse Events.

    Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.

  • Extubation Time.

    Duration from anesthesia end until extubation time.

  • Awakening Time

    Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.

  • Post Anesthesia Care Unit (PACU) Duration

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

  • Hospital Discharge Time

    Total time from end anesthesia to discharge home

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Saline

Drug: Placebo

Caffeine

ACTIVE COMPARATOR

Caffeine benzoate

Drug: Caffeine

Interventions

CaffeineDRUG

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

Caffeine
PlaceboDRUG

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

Also known as: Saline
Placebo

Eligibility Criteria

Age30 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children between 2.5-18 years old
  • Diagnosed with obstructive sleep apnea
  • Undergoing elective tonsillectomy and adenoidectomy

You may not qualify if:

  • Age below 2.5 or above 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructivePostoperative Complications

Interventions

CaffeineSodium Chloride

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Samia Khalil, M.D./ Professor
Organization
University of Texas Medical School/ Houston
Samia.N.Khalil@uth.tmc.edu
713-500-6242

Study Officials

  • Samia N. Khalil, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 4, 2006

First Posted

January 9, 2006

Study Start

September 1, 2003

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 16, 2016

Results First Posted

November 10, 2010

Record last verified: 2016-05

Locations

US(1)