Adenoidectomy, Postoperative Complications, Sleep Apnea, Obstructive, Tonsillectomy
Conditions
Keywords
Obstructive Sleep Apnea (OSA), Tonsillectomy and Adenoidectomy (T&A), Postoperative Complications, Recovery
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).
Detailed description
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.
Interventions
DRUGCaffeine
Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base.
DRUGPlacebo
Children in group two will receive an amount of normal saline equal to Caffeine
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | Duration from anesthesia end until extubation time. | Time from end of anesthesia until extubation. |
| Awakening Time | 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. |
| 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Normal Saline | 36 |
| Caffeine Caffeine benzoate | 36 |
| Total | 72 |
Baseline characteristics
| Characteristic | Caffeine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 36 Participants | 36 Participants | 72 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.3 years STANDARD_DEVIATION 2.2 | 5.3 years STANDARD_DEVIATION 2.9 | 5.3 years STANDARD_DEVIATION 2.5 |
| Region of Enrollment United States | 36 participants | 36 participants | 72 participants |
| Sex: Female, Male Female | 19 Participants | 17 Participants | 36 Participants |
| Sex: Female, Male Male | 17 Participants | 19 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
Primary
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 frame: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.
Population: The analysis was per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo. | 21 Participants |
| Caffeine | Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo. | 11 Participants |
Secondary
Awakening Time
A child with a Steward Recovery Scale score of 6 is defined as awake, coughing/crying, and has purposeful movements.
Time frame: Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Awakening Time | 26.6 Minutes | Standard Deviation 16 |
| Caffeine | Awakening Time | 26.1 Minutes | Standard Deviation 28.8 |
Secondary
Extubation Time.
Time from end of anesthesia until extubation.
Time frame: Duration from anesthesia end until extubation time.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Extubation Time. | 11.3 minutes | Standard Deviation 9.4 |
| Caffeine | Extubation Time. | 8.6 minutes | Standard Deviation 4.9 |
Secondary
Hospital Discharge Time
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.
Time frame: Total time from end anesthesia to discharge home
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Hospital Discharge Time | 107.0 Minutes | Standard Deviation 54.5 |
| Caffeine | Hospital Discharge Time | 98.2 Minutes | Standard Deviation 55.9 |
Secondary
Occurence of Post Extubatory Respiratory Adverse Events.
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.
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.
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Occurence of Post Extubatory Respiratory Adverse Events. | 34 Participants |
| Caffeine | Occurence of Post Extubatory Respiratory Adverse Events. | 17 Participants |
Secondary
Post Anesthesia Care Unit (PACU) Duration
Time frame: Time spent in PACU following surgical procedure prior to discharge home or hospital admission.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post Anesthesia Care Unit (PACU) Duration | 74.4 minutes | Standard Deviation 43.7 |
| Caffeine | Post Anesthesia Care Unit (PACU) Duration | 84.8 minutes | Standard Deviation 44.1 |