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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03062488
Recruitment Status : Completed
First Posted : February 23, 2017
Results First Posted : January 15, 2020
Last Update Posted : January 15, 2020
University of Central Florida
Information provided by (Responsible Party):
Nemours Children's Clinic

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.

Condition or disease Intervention/treatment Phase
Emergence Agitation Pain Drug: IV acetaminophen Drug: Fentanyl Drug: PO acetaminophen Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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
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

Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 3, 2017
Actual Primary Completion Date : July 11, 2018
Actual Study Completion Date : July 11, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: opioid only
2 mcg/Kg of fentanyl
Drug: Fentanyl
single modal analgesia
Other Name: duragesic

Active Comparator: opioid plus PO analgesic
2 mcg/Kg of fentanyl plus PO acetaminophen 15 mg/Kg
Drug: Fentanyl
single modal analgesia
Other Name: duragesic

Drug: PO acetaminophen
multi-modal analgesia with PO acetaminophen
Other Name: tylenol

Active Comparator: opioid plus IV acetaminophen
2 mcg/Kg of fentanyl plus 15mg/Kg of IV acetaminophen
Drug: IV acetaminophen
multi-modal analgesia with IV acetaminophen
Other Name: Ofirmev

Drug: Fentanyl
single modal analgesia
Other Name: duragesic

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Post Operative Pain [ Time Frame: Average in first 60 minutes of recovery post anesthesia ]
    Measured on scale of 0-10 0-3 = mild pain 4-6 = moderate pain 7-10 = severe pain Tools used for each age subgroup: FLACC Score for patients 24 months to 4 years of age and sedated patients at time of assessment, Wong-Baker FACES for patients between 4 and 7 years of age, and Numeric Pain Scores for patients equal/greater than 7 years of age

  2. Post Operative Fentanyl Consumption [ Time Frame: first 60 minutes in the PACU ]
    Post operative administration of fentanyl in micrograms per Kilogram of weight after intra-operative pain management in the Post Anesthesia Care Unit (PACU)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   24 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03062488

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United States, Florida
Nemours Children's Specialty Care
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
University of Central Florida
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Principal Investigator: Carlos A Archilla, MD Nemours Children's Hospital
  Study Documents (Full-Text)

Documents provided by Nemours Children's Clinic:
Informed Consent Form  [PDF] January 4, 2018

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Responsible Party: Nemours Children's Clinic Identifier: NCT03062488    
Other Study ID Numbers: IRB1074554
First Posted: February 23, 2017    Key Record Dates
Results First Posted: January 15, 2020
Last Update Posted: January 15, 2020
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychomotor Agitation
Emergence Delirium
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic