Trial Outcomes & Findings for Emergence Agitation and Pain Scores in Pediatrics When Comparing Single-modal vs Multi-modal Analgesia for ENT Surgery (NCT NCT03062488)

NCT ID: NCT03062488

Last Updated: 2020-01-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 143 participants
• Primary outcome timeframe: first 60 minutes of recovery post anesthesia
• Results posted on: 2020-01-18

Participant Flow

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

No events. Patients were screened prior to pre-enrollment.

Participant milestones

Measure	Opioid Only 2 mcg/Kg of fentanyl Fentanyl: single modal analgesia	Opioid Plus PO Analgesic 2 mcg/Kg of fentanyl plus PO acetaminophen 15 mg/Kg Fentanyl: single modal analgesia PO acetaminophen: multi-modal analgesia with PO acetaminophen	Opioid Plus IV 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 Study STARTED	51	51	41
Overall Study COMPLETED	51	51	41
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Opioid Only n=51 Participants 2 mcg/Kg of fentanyl Fentanyl: single modal analgesia	Opioid Plus PO Analgesic n=51 Participants 2 mcg/Kg of fentanyl plus PO acetaminophen 15 mg/Kg Fentanyl: single modal analgesia PO acetaminophen: multi-modal analgesia with PO acetaminophen	Opioid Plus IV Acetaminophen n=41 Participants 2 mcg/Kg of fentanyl plus 15mg/Kg of IV acetaminophen IV acetaminophen: multi-modal analgesia with IV acetaminophen Fentanyl: single modal analgesia	Total n=143 Participants Total of all reporting groups
Age, Continuous	4.49 years STANDARD_DEVIATION 1.5 • n=5 Participants	4.9 years STANDARD_DEVIATION 1.58 • n=7 Participants	4.61 years STANDARD_DEVIATION 1.28 • n=5 Participants	4.7 years STANDARD_DEVIATION 1.5 • n=4 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	26 Participants n=7 Participants	19 Participants n=5 Participants	74 Participants n=4 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	25 Participants n=7 Participants	22 Participants n=5 Participants	69 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	16 Participants n=7 Participants	12 Participants n=5 Participants	42 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	35 Participants n=7 Participants	29 Participants n=5 Participants	101 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Weight	19.99 Kg STANDARD_DEVIATION 5.81 • n=5 Participants	21.79 Kg STANDARD_DEVIATION 5.94 • n=7 Participants	20.94 Kg STANDARD_DEVIATION 5.39 • n=5 Participants	20.9 Kg STANDARD_DEVIATION 5.7 • n=4 Participants
body mass index	16.59 Kg/m² STANDARD_DEVIATION 2.31 • n=5 Participants	17.21 Kg/m² STANDARD_DEVIATION 3.35 • n=7 Participants	16.70 Kg/m² STANDARD_DEVIATION 2.67 • n=5 Participants	16.8 Kg/m² STANDARD_DEVIATION 2.8 • n=4 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Opioid Only n=51 Participants 2 mcg/Kg of fentanyl Fentanyl: single modal analgesia	Opioid Plus PO Analgesic n=51 Participants 2 mcg/Kg of fentanyl plus PO acetaminophen 15 mg/Kg Fentanyl: single modal analgesia PO acetaminophen: multi-modal analgesia with PO acetaminophen	Opioid Plus IV Acetaminophen n=41 Participants 2 mcg/Kg of fentanyl plus 15mg/Kg of IV acetaminophen IV acetaminophen: multi-modal analgesia with IV acetaminophen Fentanyl: single modal analgesia
Emergence Agitation (EA) as Measured by Standardized PAED Scale	5.3 score on a scale Standard Deviation 2.77	4.99 score on a scale Standard Deviation 2.6	6.29 score on a scale Standard Deviation 2.85

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Opioid Only n=51 Participants 2 mcg/Kg of fentanyl Fentanyl: single modal analgesia	Opioid Plus PO Analgesic n=51 Participants 2 mcg/Kg of fentanyl plus PO acetaminophen 15 mg/Kg Fentanyl: single modal analgesia PO acetaminophen: multi-modal analgesia with PO acetaminophen	Opioid Plus IV Acetaminophen n=41 Participants 2 mcg/Kg of fentanyl plus 15mg/Kg of IV acetaminophen IV acetaminophen: multi-modal analgesia with IV acetaminophen Fentanyl: single modal analgesia
Post Operative Pain	2.58 score on a scale Standard Deviation 1.86	2.56 score on a scale Standard Deviation 1.60	2.51 score on a scale Standard Deviation 1.83

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Opioid Only n=51 Participants 2 mcg/Kg of fentanyl Fentanyl: single modal analgesia	Opioid Plus PO Analgesic n=51 Participants 2 mcg/Kg of fentanyl plus PO acetaminophen 15 mg/Kg Fentanyl: single modal analgesia PO acetaminophen: multi-modal analgesia with PO acetaminophen	Opioid Plus IV Acetaminophen n=41 Participants 2 mcg/Kg of fentanyl plus 15mg/Kg of IV acetaminophen IV acetaminophen: multi-modal analgesia with IV acetaminophen Fentanyl: single modal analgesia
Post Operative Fentanyl Consumption	0.64 microgram per Kg of weight Standard Deviation 0.50	0.72 microgram per Kg of weight Standard Deviation 0.61	0.58 microgram per Kg of weight Standard Deviation 0.52

Adverse Events

Opioid Only

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Opioid Plus PO Analgesic

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Opioid Plus IV Acetaminophen

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Opioid Only n=51 participants at risk 2 mcg/Kg of fentanyl Fentanyl: single modal analgesia	Opioid Plus PO Analgesic n=51 participants at risk 2 mcg/Kg of fentanyl plus PO acetaminophen 15 mg/Kg Fentanyl: single modal analgesia PO acetaminophen: multi-modal analgesia with PO acetaminophen	Opioid Plus IV Acetaminophen n=41 participants at risk 2 mcg/Kg of fentanyl plus 15mg/Kg of IV acetaminophen IV acetaminophen: multi-modal analgesia with IV acetaminophen Fentanyl: single modal analgesia
General disorders Shivering	0.00% 0/51 • 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	2.0% 1/51 • Number of events 1 • 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	0.00% 0/41 • 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
Respiratory, thoracic and mediastinal disorders Breath Holding	0.00% 0/51 • 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	0.00% 0/51 • 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	2.4% 1/41 • Number of events 1 • 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
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/51 • 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	2.0% 1/51 • Number of events 1 • 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	0.00% 0/41 • 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
General disorders Excessive Secretions	2.0% 1/51 • Number of events 1 • 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	0.00% 0/51 • 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	0.00% 0/41 • 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
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/51 • 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	2.0% 1/51 • Number of events 1 • 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	4.9% 2/41 • Number of events 2 • 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
Gastrointestinal disorders Abdominal Pain	2.0% 1/51 • Number of events 1 • 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	0.00% 0/51 • 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	0.00% 0/41 • 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
Gastrointestinal disorders Nausea	2.0% 1/51 • Number of events 1 • 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	2.0% 1/51 • Number of events 1 • 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	0.00% 0/41 • 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
Psychiatric disorders Emergence Agitation (EA) Pharmacological Treatment	5.9% 3/51 • Number of events 3 • 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	9.8% 5/51 • Number of events 5 • 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	19.5% 8/41 • Number of events 8 • 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
Respiratory, thoracic and mediastinal disorders Croup	2.0% 1/51 • Number of events 1 • 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	2.0% 1/51 • Number of events 1 • 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	0.00% 0/41 • 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
Gastrointestinal disorders Vomiting	5.9% 3/51 • Number of events 3 • 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	3.9% 2/51 • Number of events 2 • 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	4.9% 2/41 • Number of events 2 • 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
General disorders Fever	2.0% 1/51 • Number of events 1 • 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	2.0% 1/51 • Number of events 1 • 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	0.00% 0/41 • 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
Gastrointestinal disorders Dysphagia	0.00% 0/51 • 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	2.0% 1/51 • Number of events 1 • 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	0.00% 0/41 • 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
Respiratory, thoracic and mediastinal disorders Respiratory Depression	0.00% 0/51 • 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	2.0% 1/51 • Number of events 1 • 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	0.00% 0/41 • 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
Skin and subcutaneous tissue disorders Rash	2.0% 1/51 • Number of events 1 • 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	0.00% 0/51 • 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	0.00% 0/41 • 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
Gastrointestinal disorders Decreased Oral Intake	2.0% 1/51 • Number of events 1 • 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	2.0% 1/51 • Number of events 1 • 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	0.00% 0/41 • 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
General disorders Hypothermia	0.00% 0/51 • 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	2.0% 1/51 • Number of events 1 • 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	0.00% 0/41 • 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
General disorders Pain - Excessive	0.00% 0/51 • 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	0.00% 0/51 • 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	2.4% 1/41 • Number of events 1 • 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
General disorders Dizziness	0.00% 0/51 • 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	0.00% 0/51 • 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	2.4% 1/41 • Number of events 1 • 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

Additional Information

Carlos A. Archilla, MD

Nemours Children's Healthcare System

Phone: 4076507646

Email: carlos.archilla@nemours.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place