Emergence Agitation and Pain Scores in Pediatric Patients Following Sevoflurane Anesthesia When Comparing Single-modal Versus Multi-modal Analgesia for Routine Ear-nose-throat (ENT) Surgery, a Multi-center Double-blinded Study
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Nemours Children's Clinic
- Enrollment
- 143
- Locations
- 1
- Primary Endpoint
- Emergence Agitation (EA) as Measured by Standardized PAED Scale
Study Overview
Brief 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.
Detailed Description
Place of Study:
Nemours Children's Hospital, Orlando, Florida (Primary Site) Wolfson Children's Hospital, Jacksonville, Florida (Nemours Jacksonville Satellite Site)
Study Design:
Prospective Randomized Study Total Number of Patients: 150
Methods and Materials: 150 patients will be randomly divided into three groups of 50 patients. Each group will receive sevoflurane induction and maintenance of anesthesia. Sevoflurane, currently the most commonly used agent for inhalational induction, will be used for induction of anesthesia, as it is less irritating to the tracheobronchial tree than other volatile anesthetic agents and is considered the standard for pediatric induction anesthesia. These three groups, (study arms), are identified as follows:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
all patients will receive a de-identified PO syrup. The syrup will be prepared by the pharmacy and will contain acetaminophen (15 mg/kg) for the PO acetaminophen group and placebo flavored syrup for the other two groups. This approach will maintain blindness of the peri-operative staff, and patients/parents., all children will receive fentanyl 2 mcg/Kg IV. Intra-op anesthesia team will be blinded to the use of non-opioid IV analgesia and will administer a pharmacy prepared de-identified infusion following intubation that will consist of saline placebo for control groups and IV acetaminophen (15 mg/kg) for the IV acetaminophen group. ,
:A blinded PACU nurse will record degree of agitation using the PAED scale on admission to the PACU
Eligibility Criteria
- Ages
- 24 Months to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
opioid plus IV acetaminophen
2 mcg/Kg of fentanyl plus 15mg/Kg of IV acetaminophen
Intervention: Fentanyl (Drug)
opioid plus IV acetaminophen
2 mcg/Kg of fentanyl plus 15mg/Kg of IV acetaminophen
Intervention: IV acetaminophen (Drug)
opioid only
2 mcg/Kg of fentanyl
Intervention: Fentanyl (Drug)
opioid plus PO analgesic
2 mcg/Kg of fentanyl plus PO acetaminophen 15 mg/Kg
Intervention: Fentanyl (Drug)
opioid plus PO analgesic
2 mcg/Kg of fentanyl plus PO acetaminophen 15 mg/Kg
Intervention: PO acetaminophen (Drug)
Outcomes
Primary Outcomes
Emergence Agitation (EA) as Measured by Standardized PAED Scale
Time Frame: first 60 minutes of recovery post anesthesia
Post Anesthesia Emergence Delirium (PAED) Scale 0 - 20. EA defined as a score equal or greater than 12
Secondary Outcomes
- Post Operative Pain(Average in first 60 minutes of recovery post anesthesia)
- Post Operative Fentanyl Consumption(first 60 minutes in the PACU)