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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Emergence Agitation, Pain

In brief

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.

Key facts

Study ID

NCT03062488

Run by

Nemours Children's Clinic

People needed

143

Starts

2017-10-03

Expected to finish

2018-07-11

Last updated by the study team

2020-01-18

Who can join

Age: 2 and older, up to 7. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients who are 24 months through 7 years of age
• Patients who weigh <50 kg
• Patients who are able to take PO medications
• Patients who are ASA Classification I and II
• Patients who are found to be a candidate after clinical review of detailed History and Physical Exam, review of Polysomnogram or Pediatric Sleep Questionnaire
• Patients who are scheduled for routine adenoidectomy or tonsillectomy with or without adenoidectomy not in conjunction with another invasive or diagnostic procedure
• Patients who meet clinical indications for surgery
• Family and patient must be proficient in English to understand consent, post-operative instructions, and facilitate the assessment after emergence of anesthesia

You may not qualify if…

• 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
• Patients with previous hypersensitivity to oral or intravenous acetaminophen, fentanyl or any of its components or ingredients in placebo,
• Patients with severe hepatic impairment or severe active hepatic disease
• Patients with previous history of Malignant Hyperthermia or susceptibility to volatile anesthetics agents like sevoflurane
• Any patient who weighs >50 Kg.
• 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.
• Patients unable to take PO (acetaminophen or placebo) will be excluded from the study.
• Children with severe symptomatic sleep apnea that require post-operative hospitalization.
• 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)
• Patients with severe symptoms and findings in physical exam that require post-operative hospital admission.
• Patients and/or families not proficient in English
• Participant is currently participating or has within the previous 30 days, participated in another clinical trial/research study

Where it is running

• Nemours Children's Specialty Care — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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