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

NCT03062488 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: IRB1074554
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Agitation; Pain

Outcome Measures

Primary Outcomes (1)

• Emergence Agitation (EA) as Measured by Standardized PAED Scale

  Post Anesthesia Emergence Delirium (PAED) Scale 0 - 20. EA defined as a score equal or greater than 12

  first 60 minutes of recovery post anesthesia

Secondary Outcomes (2)

• Post Operative Pain

  Average in first 60 minutes of recovery post anesthesia

• Post Operative Fentanyl Consumption

  first 60 minutes in the PACU

Study Arms (3)

opioid only

ACTIVE COMPARATOR

2 mcg/Kg of fentanyl

Drug: Fentanyl

opioid plus PO analgesic

ACTIVE COMPARATOR

2 mcg/Kg of fentanyl plus PO acetaminophen 15 mg/Kg

Drug: Fentanyl; Drug: PO acetaminophen

opioid plus IV acetaminophen

ACTIVE COMPARATOR

2 mcg/Kg of fentanyl plus 15mg/Kg of IV acetaminophen

Drug: IV acetaminophen; Drug: Fentanyl

Interventions

IV acetaminophen DRUG

multi-modal analgesia with IV acetaminophen

Also known as: Ofirmev

opioid plus IV acetaminophen

Fentanyl DRUG

single modal analgesia

Also known as: duragesic

opioid only; opioid plus IV acetaminophen; opioid plus PO analgesic

PO acetaminophen DRUG

multi-modal analgesia with PO acetaminophen

Also known as: tylenol

opioid plus PO analgesic

Eligibility Criteria

• Age: 24 Months - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• University of Central Florida: collaborator

Study Sites (1)

Nemours Children's Specialty Care

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Emergence Delirium; Pain

Interventions

Acetaminophen; Fentanyl

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Carlos A. Archilla, MD
• Organization: Nemours Children's Healthcare System

carlos.archilla@nemours.org

4076507646

Study Officials

• Carlos A Archilla, MD

  Nemours Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study Design: 1. Prospective Randomized Study 2. Study Period: August 2017 - December 2017 3. Potential participants: 375 - 475 based on 20-25% of 4,459 ENT patients in 2016 4. Study Population: 50 pediatric patients in each group between 24 months through 7 years of age undergoing adenoidectomy or tonsillectomy with or without adenoidectomy Total Number of Patients: 150

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 23, 2017
• Study Start: October 3, 2017
• Primary Completion: July 11, 2018
• Study Completion: July 11, 2018
• Last Updated: January 18, 2020
• Results First Posted: January 18, 2020

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)