Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study

NCT01349205 | Terminated DMC

• 1 other identifier: HSC-MS-09-0457
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate whether a smaller dose of caffeine sodium benzoate 10 mg/kg IV is as effective as 20 mg/kg IV in decreasing the number of children who develop post extubation adverse upper airway respiratory events compared to placebo.

Conditions

Obstructive Sleep Apnea; Enlargement of Tonsil or Adenoid

Keywords

OSA; Caffeine; Tonsillectomy; Adenoidectomy; Sleep Study

Outcome Measures

Primary Outcomes (1)

• Effects of Caffeine

  The primary outcome of the study is the number of children who develop adverse postextubation respiratory events, including: 1) airway obstruction, requiring jaw-chin thrust maneuver, or placement of an LMA or endotracheal tube, 2) laryngospasm, requiring continuous positive airway pressure or intervention with a muscle relaxant, 3) apnea, 4) desaturation(defined as a decrease in oxygen saturation \<95% while breathing oxygen via mask which is our hospital and PACU nurses standard of care), 5) hypoventilation/ hypercapnia )

  Immediately after drug administration upto 24 hours

Secondary Outcomes (1)

• Caffeine Drug Effects

  Immediately after drug administration to 24 hours

Study Arms (3)

Caffeine and Sodium Benzoate 10 mg/kg IV

EXPERIMENTAL

Group 1 of randomized study.

Drug: Caffeine and sodium Benzoate 10 mg/kg IV

Caffeine and Sodium Benzoate 20 mg/kg IV

EXPERIMENTAL

Group 2 of randomized study

Drug: Caffeine and Sodium Benzoate 20 mg/kg IV

0.9 NS Saline

PLACEBO COMPARATOR

Control group of randomized study.

Drug: 0.9 NS Saline

Interventions

Caffeine and sodium Benzoate 10 mg/kg IV DRUG

IV, 10mg/kg, IVP, 1 time

Caffeine and Sodium Benzoate 10 mg/kg IV

Caffeine and Sodium Benzoate 20 mg/kg IV DRUG

IV, 20 mg/kg, IVP, 1 time

Caffeine and Sodium Benzoate 20 mg/kg IV

0.9 NS Saline DRUG

IV, 0-10 ml, IVP, 1 time

0.9 NS Saline

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with OSA and/or increased end tidal C02 (sleep related hypoventilation, obstructive hypoventilation or sustained alveolar hypoventilation), 2-12 years of age, and both genders will be eligible to be part of the study. OSA and its severity will be diagnosed by a preoperative polysomnography.

You may not qualify if:

• Children with compromised cardiovascular, pulmonary or renal function, those with congenital syndromes, sickle cell disease, history of seizures and those receiving theophylline will be excluded.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Memorial Hermann Hospital: collaborator

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Caffeine; Sodium Benzoate

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzoic Acid; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• samia Khalil, MD

  Memorial Hermann Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Anesthesiology

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 6, 2011
• Study Start: March 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

US (1)