Predicting Risk Factors in Children With Obstructive Sleep Apnea Undergoing Adenotonsillectomy Surgery

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 60
• Participant gender: Both

Summary

Adenotonsillectomy (AT) is one of the most common pediatric surgeries performed, and is estimated to comprise 530,000 procedures in children under 15 years of age. Historically, the leading cause for these procedures was recurrent infections; however, more recently surgical indications include sleep disordered breathing and obstructive sleep apnea (OSA). Pre-operative polysomnography (PSG) is recommended for all children with suspected OSA prior to undergoing AT, although it is unclear whether sleep disordered breathing characteristics predict post-operative outcomes or complications.

Obesity has become an epidemic in our pediatric population. More recently, an increased population of obese children are presenting for AT with upper airway obstruction with or without tonsillar hypertrophy, which is similar to the adult etiology of OSA. Obesity is a multisystem disease, causing fatty liver and cardiac disease, defects in glucose metabolism, insulin resistance, leptin resistance, and creates a state of chronic inflammation. Markers for inflammation, including TNF-α, CRP, leptin, IL-6 and IL-10, are abnormal in obese patients and have also been linked to more severe OSA disease in children even after controlling for BMI.

In pediatrics, medication dosing is based on an actual body-weight calculation, however, recent reports suggest that this dosing method is over-dosing patients with obesity. Therefore, increased respiratory complications after surgery may be related to inappropriate intra-operative opioid dosing.

Specific Aim 1 (SA1): To compare analgesic-guided opioid dosing using actual body weight (ABW) based dosing versus ideal body weight (IBW) dosing for adenotonsillectomy in children with OSA (BMI >/=75%).

The investigators hypothesize that 1) weight-based opioid dosing compared to dosing based on ideal body weight leads to increased respiratory complications defined by (a) upper airway obstruction, (b) hypoventilation, and (c) oxygen desaturation without affecting pain scores immediately after adenotonsillectomy. In addition, the investigators believe 2) that there will be little statistically significant difference in pain scores between ABW and IBW for these patients.

Specific Aim 2 (SA2): To determine whether biomarkers related to obesity, chronic inflammation, and OSA predict post-operative respiratory compromise after AT. The investigators hypothesize that inflammatory and obesity-related biomarkers are elevated in overweight children with OSA, more so in obese children with OSA, compared to lean children with OSA.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Morphine
• Last Updated: 2016-04-04

Criteria

Inclusion Criteria:

• Physician diagnosis of OSA presenting for adenotonsillectomy

• Age between 2 -12 years of age

• Pre-operative polysomnography study conducted prior to day of surgery

Exclusion Criteria:

• Emergency procedures involving AT, including tonsillar bleeding

• Procedures involving AT in addition to other surgeries at other anatomic locations (except myringotomy)

• Patients with contra-indications for standardized anesthesia medications, such as allergy or comorbidities (i.e. liver disease preventing Tylenol administration)

• Patients with co-morbidities that cause upper airway collapse (i.e: patients with craniofacial syndromes, neuro-muscular disorders, genetic/metabolic syndromes, etc.)

• Patients with chronic inflammatory, rheumatologic, or other confounding co-morbid diseases (i.e. Crohns disease, ulcerative colitis, sickle cell, Sjogren's, etc.)