Emergence Agitation and Pain Scores in Pediatrics When Comparing Single-modal vs Multi-modal Analgesia for ENT Surgery

• Status: Completed
• Trial end date: 2018-07-11
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the incidence of EA in pediatric patients undergoing minor ENT surgery under Sevoflurane and compare opioid-only based intra-operative analgesia to multi-modal analgesia consisting of opioid and IV acetaminophen or PO acetaminophen regimen using a validated and standardized EA measurement tool, the Pediatric Anesthesia Emergence Delirium (PAED) scale. The post operative pain scores will be measured in all patients by post-op recovery staff using FLACC Score/Wong-Baker FACES (patients 24 months up to 7 years of age) or Numeric Pain Score for patients 7 years of age. The pre-operative, surgery, anesthesia and post-operative staff will be all blinded.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nemours Children's Clinic
• Collaborator: University of Central Florida
• Treatments: Acetaminophen; Fentanyl

Criteria

Inclusion Criteria:

1. Patients who are 24 months through 7 years of age

2. Patients who weigh <50 kg

3. Patients who are able to take PO medications

4. Patients who are ASA Classification I and II

5. Patients who are found to be a candidate after clinical review of detailed History and Physical Exam, review of Polysomnogram or Pediatric Sleep Questionnaire

6. Patients who are scheduled for routine adenoidectomy or tonsillectomy with or without adenoidectomy not in conjunction with another invasive or diagnostic procedure

7. Patients who meet clinical indications for surgery

8. Family and patient must be proficient in English to understand consent, post-operative instructions, and facilitate the assessment after emergence of anesthesia

Exclusion Criteria:

1. Children with a history of developmental delay or psychological disorders that may be at higher risk for EA as determined by study physician after review of history and problem list in EMR

2. Patients with previous hypersensitivity to oral or intravenous acetaminophen, fentanyl or any of its components or ingredients in placebo,

3. Patients with severe hepatic impairment or severe active hepatic disease

4. Patients with previous history of Malignant Hyperthermia or susceptibility to volatile anesthetics agents like sevoflurane

5. Any patient who weighs >50 Kg.

6. Any patient that requires premedication. Versed may contribute to an increase in EA. Premedication is reserved when parental presence is not feasible or for very anxious children.

7. Patients unable to take PO (acetaminophen or placebo) will be excluded from the study.

8. Children with severe symptomatic sleep apnea that require post-operative hospitalization.

9. Severe symptomatic sleep apnea is defined as a- patients who has a pre-operative polysomnogram and a calculated Apnea-Hypoxia Index greater than 10 b- patients with high scoring in Pediatric Sleep Questionnaire (PSQ)

10. Patients with severe symptoms and findings in physical exam that require post-operative hospital admission.

11. Patients and/or families not proficient in English

12. Participant is currently participating or has within the previous 30 days, participated in another clinical trial/research study