Obstructive Sleep Apnea, Respiratory Depression
Conditions
Keywords
pediatrics, opioids, obstructive sleep apnea
Brief summary
The sole objective in this study is to evaluate if routine amounts of opioids given for tonsillectomy in children have greater amounts of respiratory depression in children with documented obstructive sleep apnea when compared with patients that do not have obstructive sleep apnea
Detailed description
Ventilatory suppression in children following opioid administration is of obvious concern, especially following routine surgical procedures (i.e. adenotonsillectomy). It is thought that patients with obstructive sleep apnea (OSA) have increased sensitivity to opioids, and especially in opioid naïve patients. Recent evidence in adults suggests that patients with moderate to severe OSA may not predispose patients to increased opioid sensitivity in the form of respiratory depression when compared with patients that do not have OSA. It is well known that OSA in children is significantly different from OSA in adults (e.g. gender predilection, central vs. peripheral causation). The manifestation and etiologies are very different in pediatric OSA making it a vastly different disease process.
Interventions
DRUGFentanyl
identification of respiratory parameter changes following administration of fentanyl in children with and without OSA
Sponsors
Baylor College of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* tonsillectomy or adenotonsillectomy * Ages 2 to 8 years * Polysomnography with AHI \>6 (study group) * Polysomnography with AHI =0 or negative OSA 18 questionnaire (control group)
Exclusion criteria
* Ages \>8 years * Patients requiring pre-medication * Parental refusal * Opioid allergy/intolerance * Patients requiring propofol for intubation * Patients with known or suspected difficult airway * Obesity with body mass index exceeding 30- (control group only) * Known cardiovascular disorders * Known pulmonary disorders aside from asthma * Patients with chronic oxygen requirement * History of Prematurity \<35 weeks of gestation * No recent URI * Personal of family history of malignant hyperthermia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Depression Following Opioids | Mean respiratory rate % change from baseline measured 10 minutes following opioid administration | Identification of respiratory depression following routine fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group; Patients Without Obstructive Sleep Apnea Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes
Fentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA | 20 |
| Patients With Known Obstructive Sleep Apnea Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes
Fentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA | 30 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | unable to establish baseline for ventilation | 1 | 1 |
Baseline characteristics
| Characteristic | Control Group; Patients Without Obstructive Sleep Apnea | Total | Patients With Known Obstructive Sleep Apnea |
|---|---|---|---|
| Age, Continuous | 4.6 years STANDARD_DEVIATION 1.5 | 4 years STANDARD_DEVIATION 1.7 | 3.6 years STANDARD_DEVIATION 1.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 20 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 30 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 37 Participants | 23 Participants |
| Region of Enrollment United States | 20 Participants | 50 Participants | 30 Participants |
| Sex: Female, Male Female | 6 Participants | 17 Participants | 11 Participants |
| Sex: Female, Male Male | 14 Participants | 33 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 30 |
| other Total, other adverse events | 0 / 20 | 0 / 30 |
| serious Total, serious adverse events | 0 / 20 | 0 / 30 |
Outcome results
Primary
Respiratory Depression Following Opioids
Identification of respiratory depression following routine fentanyl administration by recording the end-tidal co2 % change from baseline prior to and 10 minutes following fentanyl administration
Time frame: mean percentage of change from baseline in end tidal co2 measured 10 minutes following opioid administration
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Group; Patients Without Obstructive Sleep Apnea | Respiratory Depression Following Opioids | 4.0 percentage of change from baseline |
| Patients With Known Obstructive Sleep Apnea | Respiratory Depression Following Opioids | 2.2 percentage of change from baseline |
Primary
Respiratory Depression Following Opioids
Identification of respiratory depression following routine fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration
Time frame: Mean respiratory rate % change from baseline measured 10 minutes following opioid administration
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Group; Patients Without Obstructive Sleep Apnea | Respiratory Depression Following Opioids | -38.1 percentage of change from baseline |
| Patients With Known Obstructive Sleep Apnea | Respiratory Depression Following Opioids | -37.1 percentage of change from baseline |
Primary
Respiratory Depression Following Opioids
Identification of respiratory depression following routine fentanyl administration by recording the tidal volume % change from baseline prior to and 10 minutes following fentanyl administration
Time frame: mean percentage of change from baseline in tidal volume measured 10 minutes following opioid administration
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Group; Patients Without Obstructive Sleep Apnea | Respiratory Depression Following Opioids | 6.4 percentage of change from baseline |
| Patients With Known Obstructive Sleep Apnea | Respiratory Depression Following Opioids | 5.4 percentage of change from baseline |