Pain Clinical Trial
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
Verified date | August 2017 |
Source | Nemours Children's Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 143 |
Est. completion date | July 11, 2018 |
Est. primary completion date | July 11, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 24 Months to 7 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Nemours Children's Specialty Care | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Nemours Children's Clinic | University of Central Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Post Operative Pain | 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 | Average in first 60 minutes of recovery post anesthesia | |
Secondary | Post Operative Fentanyl Consumption | Post operative administration of fentanyl in micrograms per Kilogram of weight after intra-operative pain management in the Post Anesthesia Care Unit (PACU) | first 60 minutes in the PACU |
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