Obstructive Sleep ApneaNCT01349205
Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study
A study testing Caffeine and sodium Benzoate 10 mg/kg IV, Caffeine and Sodium Benzoate 20 mg/kg IV and 0.9 NS Saline in people with Obstructive Sleep Apnea and Enlargement of Tonsil or Adenoid, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Enlargement of Tonsil or Adenoid
- What is being tested?
- Caffeine and sodium Benzoate 10 mg/kg IV, Caffeine and Sodium Benzoate 20 mg/kg IV and 0.9 NS Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Institutional approval and written informed consent from parents or guardians of healthy children, with obstructive sleep apnea (OSA) and/or with increased end-tidal C02 (sleep related hypoventilation, obstructive hypoventilation or sustained alveolar hypoventilation), confirmed with sleep study, scheduled for elective outpatient or inpatient adeno-tonsillectomy at our hospital, will be obtained. The study will be prospective, randomized, double blinded and placebo controlled. A computer generated randomization list will be used, and the study will be registered with clinical.trials.gov. Written child assent will be obtained from children 7 years and older. Copies of a flyer and an explanation of the study will be provided at the office of all the pediatric ENT surgeons who practice at the Memorial Hermann Hospital OR. The investigators will communicate with the nurses at the surgeons' office and ask them to give the flyer with an explanation of the study to the parents and children on the day they schedule the surgery. The flyer with an explanation of study will be sent to IRB for review and approval. A research assistant will invite parents or guardians in the DSU unit, anesthesia clinic or on the floor to allow their children to be part of the study. 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. 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.
- Being tested
- Caffeine and sodium Benzoate 10 mg/kg IV, Caffeine and Sodium Benzoate 20 mg/kg IV, 0.9 NS Saline
- Keywords
- OSA, Caffeine, Tonsillectomy, Adenoidectomy, Sleep Study
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine and sodium Benzoate 10 mg/kg IVDrug
IV, 10mg/kg, IVP, 1 time
Caffeine and Sodium Benzoate 20 mg/kg IVDrug
IV, 20 mg/kg, IVP, 1 time
0.9 NS SalineDrug
IV, 0-10 ml, IVP, 1 time
| Study group | Role | What they receive |
|---|---|---|
| Caffeine and Sodium Benzoate 10 mg/kg IV | Experimental | Group 1 of randomized study. Receives: Drug: Caffeine and sodium Benzoate 10 mg/kg IV |
| Caffeine and Sodium Benzoate 20 mg/kg IV | Experimental | Group 2 of randomized study Receives: Drug: Caffeine and Sodium Benzoate 20 mg/kg IV |
| 0.9 NS Saline | Placebo comparator | Control group of randomized study. Receives: Drug: 0.9 NS Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: Immediately after drug administration upto 24 hours
Secondary outcomes (1)
Caffeine Drug Effects
A secondary outcome of the study will be the incidence of adverse post-extubation respiratory events.
Measured: Immediately after drug administration to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startMar 2010
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: The study medication was no longer available in the market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Hermann Hospital
- Responsible party
- Principal investigator, Samia Khalil, The University of Texas Health Science Center, Houston
- Investigators
- samia Khalil, MD, Principal investigator, Memorial Hermann Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349205
- Sponsor's protocol ID
- HSC-MS-09-0457
- Other IDs
- HSC-MS-09-0457
- Status last verified
- May 2016
- First submitted
- 3 May 2011
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study
- ClinicalTrials.gov ID
- NCT01349205
- Acronym / sponsor ID
- HSC-MS-09-0457
- Keywords
- OSA, Caffeine, Tonsillectomy, Adenoidectomy, Sleep Study
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study medication was no longer available in the market
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Memorial Hermann Hospital
- Study start
- Mar 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Institutional approval and written informed consent from parents or guardians of healthy children, with obstructive sleep apnea (OSA) and/or with increased end-tidal C02 (sleep related hypoventilation, obstructive hypoventilation or sustained alveolar hypoventilation), confirmed with sleep study, scheduled for elective outpatient or inpatient adeno-tonsillectomy at our hospital, will be obtained. The study will be prospective, randomized, double blinded and placebo controlled. A computer generated randomization list will be used, and the study will be registered with clinical.trials.gov. Written child assent will be obtained from children 7 years and older. Copies of a flyer and an explanation of the study will be provided at the office of all the pediatric ENT surgeons who practice at the Memorial Hermann Hospital OR. The investigators will communicate with the nurses at the surgeons' office and ask them to give the flyer with an explanation of the study to the parents and children on the day they schedule the surgery. The flyer with an explanation of study will be sent to IRB for review and approval. A research assistant will invite parents or guardians in the DSU unit, anesthesia clinic or on the floor to allow their children to be part of the study. 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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caffeine and Sodium Benzoate 10 mg/kg IV | Experimental | Drug: Caffeine and sodium Benzoate 10 mg/kg IVGroup 1 of randomized study. |
| Caffeine and Sodium Benzoate 20 mg/kg IV | Experimental | Drug: Caffeine and Sodium Benzoate 20 mg/kg IVGroup 2 of randomized study |
| 0.9 NS Saline | Placebo comparator | Drug: 0.9 NS SalineControl group of randomized study. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine and sodium Benzoate 10 mg/kg IVIV, 10mg/kg, IVP, 1 time | Drug | Caffeine and Sodium Benzoate 10 mg/kg IV |
| Caffeine and Sodium Benzoate 20 mg/kg IVIV, 20 mg/kg, IVP, 1 time | Drug | Caffeine and Sodium Benzoate 20 mg/kg IV |
| 0.9 NS SalineIV, 0-10 ml, IVP, 1 time | Drug | 0.9 NS Saline |
Primary outcome
Effects of Caffeine
Time frame: Immediately after drug administration upto 24 hours
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 )
1 secondary outcome
Caffeine Drug Effects
Time frame: Immediately after drug administration to 24 hours
Results and safety
The study was stopped early (reason given: The study medication was no longer available in the market). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
samia Khalil, MD principal investigator
Memorial Hermann Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine and sodium Benzoate 10 mg/kg IV, Caffeine and Sodium Benzoate 20 mg/kg IV and 0.9 NS Saline in people with Obstructive Sleep Apnea and Enlargement of Tonsil or Adenoid, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study medication was no longer available in the market). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Caffeine (time frame: Immediately after drug administration upto 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.