Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

Baylor College of Medicine

Status: Completed

Conditions: Respiratory Depression; Obstructive Sleep Apnea

Treatments: Drug: Fentanyl

Study type: Observational

Funder types: Other

Identifiers

NCT03938259

H-45486

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

52 participants in 2 patient groups

Control group; patients without obstructive sleep apnea

Description:

Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes

Treatment:

Drug: Fentanyl

Patients with known obstructive sleep apnea

Description:

Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes

Treatment:

Drug: Fentanyl