Early Phase 1
N=143
Emergence Agitation and Pain Scores in Pediatrics When Comparing Single-modal vs Multi-modal Analgesia for ENT Surgery
Emergence Agitation · Pain
Bottom Line
View on ClinicalTrials.gov: NCT03062488 ↗Enrolled (actual)
143
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Emergence Agitation (EA) as Measured by Standardized PAED Scale — 5.3; 4.99; 6.29 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- IV acetaminophen (Drug); Fentanyl (Drug); PO acetaminophen (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Emergence Agitation (EA) as Measured by Standardized PAED Scale |
5.3; 4.99; 6.29 | — |
| SECONDARY Post Operative Pain |
2.58; 2.56; 2.51 | — |
| SECONDARY Post Operative Fentanyl Consumption |
0.64; 0.72; 0.58 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients who are 24 months through 7 years of age
- Patients who weigh 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
Data sourced from ClinicalTrials.gov (NCT03062488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.