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

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ClinicalTrials.gov Identifier: NCT03062488
Recruitment Status : Completed
First Posted : February 23, 2017
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
University of Central Florida
Information provided by (Responsible Party):
Nemours Children's Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Emergence Agitation
Pain
Interventions Drug: IV acetaminophen
Drug: Fentanyl
Drug: PO acetaminophen
Enrollment 143
Recruitment Details

Place of Study: Nemours Children’s Hospital, Orlando, FL and Wolfson Children’s Hospital, Jacksonville, FL

Design:

Prospective Randomized Study Study Period: October 2017-March 2018 Population: 50 pediatric patients in each group between 24 months through 7 years of age undergoing adenoidectomy or tonsillectomy with or without adenoidectomy

Pre-assignment Details No events. Patients were screened prior to pre-enrollment.
Arm/Group Title Opioid Only Opioid Plus PO Analgesic Opioid Plus IV Acetaminophen
Hide Arm/Group Description

2 mcg/Kg of fentanyl

Fentanyl: single modal analgesia

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

Fentanyl: single modal analgesia

PO acetaminophen: multi-modal analgesia with PO acetaminophen

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

IV acetaminophen: multi-modal analgesia with IV acetaminophen

Fentanyl: single modal analgesia

Period Title: Overall Study
Started 51 51 41
Completed 51 51 41
Not Completed 0 0 0
Arm/Group Title Opioid Only Opioid Plus PO Analgesic Opioid Plus IV Acetaminophen Total
Hide Arm/Group Description

2 mcg/Kg of fentanyl

Fentanyl: single modal analgesia

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

Fentanyl: single modal analgesia

PO acetaminophen: multi-modal analgesia with PO acetaminophen

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

IV acetaminophen: multi-modal analgesia with IV acetaminophen

Fentanyl: single modal analgesia

Total of all reporting groups
Overall Number of Baseline Participants 51 51 41 143
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 51 participants 41 participants 143 participants
4.49  (1.5) 4.9  (1.58) 4.61  (1.28) 4.7  (1.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 41 participants 143 participants
Female
29
  56.9%
26
  51.0%
19
  46.3%
74
  51.7%
Male
22
  43.1%
25
  49.0%
22
  53.7%
69
  48.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 41 participants 143 participants
Hispanic or Latino
14
  27.5%
16
  31.4%
12
  29.3%
42
  29.4%
Not Hispanic or Latino
37
  72.5%
35
  68.6%
29
  70.7%
101
  70.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 51 participants 51 participants 41 participants 143 participants
19.99  (5.81) 21.79  (5.94) 20.94  (5.39) 20.9  (5.7)
[1]
Measure Description: Measured in Kilograms of weight
body mass index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 51 participants 51 participants 41 participants 143 participants
16.59  (2.31) 17.21  (3.35) 16.70  (2.67) 16.8  (2.8)
[1]
Measure Description: a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters and used as an indicator of obesity and underweight.
1.Primary Outcome
Title Emergence Agitation (EA) as Measured by Standardized PAED Scale
Hide Description Post Anesthesia Emergence Delirium (PAED) Scale 0 - 20. EA defined as a score equal or greater than 12
Time Frame first 60 minutes of recovery post anesthesia
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Opioid Only Opioid Plus PO Analgesic Opioid Plus IV Acetaminophen
Hide Arm/Group Description:

2 mcg/Kg of fentanyl

Fentanyl: single modal analgesia

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

Fentanyl: single modal analgesia

PO acetaminophen: multi-modal analgesia with PO acetaminophen

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

IV acetaminophen: multi-modal analgesia with IV acetaminophen

Fentanyl: single modal analgesia

Overall Number of Participants Analyzed 51 51 41
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.3  (2.77) 4.99  (2.6) 6.29  (2.85)
2.Secondary Outcome
Title Post Operative Pain
Hide Description 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
Time Frame Average in first 60 minutes of recovery post anesthesia
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Opioid Only Opioid Plus PO Analgesic Opioid Plus IV Acetaminophen
Hide Arm/Group Description:

2 mcg/Kg of fentanyl

Fentanyl: single modal analgesia

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

Fentanyl: single modal analgesia

PO acetaminophen: multi-modal analgesia with PO acetaminophen

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

IV acetaminophen: multi-modal analgesia with IV acetaminophen

Fentanyl: single modal analgesia

Overall Number of Participants Analyzed 51 51 41
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.58  (1.86) 2.56  (1.60) 2.51  (1.83)
3.Secondary Outcome
Title Post Operative Fentanyl Consumption
Hide Description Post operative administration of fentanyl in micrograms per Kilogram of weight after intra-operative pain management in the Post Anesthesia Care Unit (PACU)
Time Frame first 60 minutes in the PACU
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Opioid Only Opioid Plus PO Analgesic Opioid Plus IV Acetaminophen
Hide Arm/Group Description:

2 mcg/Kg of fentanyl

Fentanyl: single modal analgesia

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

Fentanyl: single modal analgesia

PO acetaminophen: multi-modal analgesia with PO acetaminophen

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

IV acetaminophen: multi-modal analgesia with IV acetaminophen

Fentanyl: single modal analgesia

Overall Number of Participants Analyzed 51 51 41
Mean (Standard Deviation)
Unit of Measure: microgram per Kg of weight
0.64  (0.50) 0.72  (0.61) 0.58  (0.52)
Time Frame 24 hours. Any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure observed or measured from administration of pre-operative medication, intra-operative and immediate [postoperative periods until 24 to 48 hour follow up phone call
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Opioid Only Opioid Plus PO Analgesic Opioid Plus IV Acetaminophen
Hide Arm/Group Description

2 mcg/Kg of fentanyl

Fentanyl: single modal analgesia

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

Fentanyl: single modal analgesia

PO acetaminophen: multi-modal analgesia with PO acetaminophen

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

IV acetaminophen: multi-modal analgesia with IV acetaminophen

Fentanyl: single modal analgesia

All-Cause Mortality
Opioid Only Opioid Plus PO Analgesic Opioid Plus IV Acetaminophen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)      0/51 (0.00%)      0/41 (0.00%)    
Hide Serious Adverse Events
Opioid Only Opioid Plus PO Analgesic Opioid Plus IV Acetaminophen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/51 (0.00%)      0/51 (0.00%)      0/41 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Opioid Only Opioid Plus PO Analgesic Opioid Plus IV Acetaminophen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/51 (25.49%)      17/51 (33.33%)      15/41 (36.59%)    
Gastrointestinal disorders       
Abdominal Pain   1/51 (1.96%)  1 0/51 (0.00%)  0 0/41 (0.00%)  0
Nausea   1/51 (1.96%)  1 1/51 (1.96%)  1 0/41 (0.00%)  0
Vomiting   3/51 (5.88%)  3 2/51 (3.92%)  2 2/41 (4.88%)  2
Dysphagia   0/51 (0.00%)  0 1/51 (1.96%)  1 0/41 (0.00%)  0
Decreased Oral Intake   1/51 (1.96%)  1 1/51 (1.96%)  1 0/41 (0.00%)  0
General disorders       
Shivering   0/51 (0.00%)  0 1/51 (1.96%)  1 0/41 (0.00%)  0
Excessive Secretions   1/51 (1.96%)  1 0/51 (0.00%)  0 0/41 (0.00%)  0
Fever   1/51 (1.96%)  1 1/51 (1.96%)  1 0/41 (0.00%)  0
Hypothermia   0/51 (0.00%)  0 1/51 (1.96%)  1 0/41 (0.00%)  0
Pain - Excessive   0/51 (0.00%)  0 0/51 (0.00%)  0 1/41 (2.44%)  1
Dizziness   0/51 (0.00%)  0 0/51 (0.00%)  0 1/41 (2.44%)  1
Psychiatric disorders       
Emergence Agitation (EA) Pharmacological Treatment  [1]  3/51 (5.88%)  3 5/51 (9.80%)  5 8/41 (19.51%)  8
Respiratory, thoracic and mediastinal disorders       
Breath Holding   0/51 (0.00%)  0 0/51 (0.00%)  0 1/41 (2.44%)  1
Laryngospasm   0/51 (0.00%)  0 1/51 (1.96%)  1 2/41 (4.88%)  2
Croup   1/51 (1.96%)  1 1/51 (1.96%)  1 0/41 (0.00%)  0
Respiratory Depression   0/51 (0.00%)  0 1/51 (1.96%)  1 0/41 (0.00%)  0
Skin and subcutaneous tissue disorders       
Pruritus   0/51 (0.00%)  0 1/51 (1.96%)  1 0/41 (0.00%)  0
Rash   1/51 (1.96%)  1 0/51 (0.00%)  0 0/41 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Patients who received pharmacological treatment for this
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Carlos A. Archilla, MD
Organization: Nemours Children's Healthcare System
Phone: 4076507646
EMail: carlos.archilla@nemours.org
Layout table for additonal information
Responsible Party: Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT03062488    
Other Study ID Numbers: IRB1074554
First Submitted: February 20, 2017
First Posted: February 23, 2017
Results First Submitted: December 13, 2019
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020