Can Acetaminophen Given 1-2 Hours to Children Before Ear Tube Surgery Reduce Agitation After Anesthesia?

NCT01737593 | Terminated Phase 4 Results DMC

• 1 other identifier: 12-001510
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Emergence agitation (EA) occurs in up to 67% of pediatric patients after anesthesia for bilateral myringotomy tubes (BMT, "ear tubes"). The goal of this study is to find out whether acetaminophen given well before surgery can decrease pain and therefore, decrease emergence agitation better than acetaminophen given shortly before or during surgery. EA can be dangerous for the patient because it may be hard to monitor their vital signs during an important phase of recovery, they may injure themselves, may require the presence of extra staff, and it can be very distressing to the parents. Causes of EA are not well understood, but it can be worsened by pain. 70% of patients undergoing BMT experience pain that needs treatment. Intranasal fentanyl, a strong analgesic, has been shown to decrease EA, but often ends up in dose-dependent nausea and vomiting. In previous studies and in common practice, acetaminophen is given either 30 minutes before induction of anesthesia or immediately after induction. The peak analgesic effect of acetaminophen is 60-120 minutes. Since the procedure is generally completed in 5-10 minutes, the therapeutic effect of acetaminophen may not be present upon emergence from anesthesia. The purpose of this study is to find out if acetaminophen given 60-120 minutes prior to emergence can decrease EA in patients undergoing BMT. Patients would be randomized to one of three groups: Control will receive acetaminophen rectally while under anesthesia (standard practice), Group 1 will receive acetaminophen 10 mg/kg at 60-120 minutes prior to surgery, Group 2 will receive acetaminophen 20 mg/kg at 60-120 minutes prior to surgery. All groups would also receive a dose of intranasal fentanyl during the surgery, which is standard practice. Patients would be observed in the recovery room at various time points for evidence of EA and pain.

Conditions

Emergence Agitation; Pain

Keywords

acetaminophen; emergence agitation; children; sevoflurane

Outcome Measures

Primary Outcomes (1)

• Postanesthesia Emergence Agitation (EA) Score

  EA was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale. This scale measures if the: 1. Child makes eye contact with the caregiver, 2. Child's actions are purposeful, 3. Child is aware of his/her surroundings, 4. Child is restless, 5. Child is inconsolable. Items 1, 2, and 3 are reversed scored as follows: 4 \_ not at all, 3 \_ just a little, 2 \_ quite a bit, 1 \_ very much, 0 \_ extremely. Items 4 and 5 are scored as follows: 0 \_ not at all, 1 \_ just a little, 2 \_ quite a bit, 3 \_ very much, 4\_extremely. Scores of each item are summed to obtain a total PAED scale score, range 0-20, with higher PAED scores indicating a greater degree of emergence delirium. The average PAED score of all the time points is use

  Induction,Emergence(spontaneous extremity movement),and every 5 min after emergence until the patient is discharged. This is an average of 3 hours till discharge.

Secondary Outcomes (7)

• Postanesthesia Pain Score

  Induction

• Postanesthesia Pain Score

  Emergence (spontaneous extremity movement)

• Postanesthesia Pain Score

  5 minutes post-emergence

• Postanesthesia Pain Score

  15 minutes post-emergence

• Postanesthesia Pain Score

  30 minutes post-emergence

Study Arms (3)

Acetaminophen PR

ACTIVE COMPARATOR

Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)

Drug: Acetaminophen

Acetaminophen PO-low dose

ACTIVE COMPARATOR

Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)

Drug: Acetaminophen

Acetaminophen PO-high dose

ACTIVE COMPARATOR

Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

Also known as: Tylenol

Acetaminophen PO-high dose; Acetaminophen PO-low dose; Acetaminophen PR

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients' ≥ 6 months - 6 years
• Patients must meet criteria for American Society of Anesthesiologists (ASA) physical status I, II.
• Patients must not be pre-medicated.
• Parents must give written consent on the surgery day and be able to sign informed consent form on the surgery day.
• Undergoing BMT surgery only.

You may not qualify if:

• Patients' \<6 months and \>6 years.
• Patients with known allergies to any of the medications used in this study.
• Patients with ASA status III \& IV.
• Patients taking prescription pain medications prior to surgery.
• Patients taking medication that can cause drowsiness or alter mental status (eg. benzodiazepines, cough suppressants, diphenhydramine)
• Patients with significant history of psychiatric illness, neurologic disease (seizure disorder requiring medication therapy), and developmental delay.
• Patients have been pre-medicated.
• Patients undergoing other procedures that would prolong anesthetic exposure or confound post-operative pain.
• Intra-op complication that would require prolonged anesthetic exposure.
• If patient took acetaminophen prior to surgery and was not supposed to do so
• Patients that received ketorolac or additional analgesia during surgery.
• Patients that have liver disease.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles Medical Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Emergence Delirium; Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Wendy Ren
• Organization: UCLA

wren@mednet.ucla.edu

310.267.8678

Study Officials

• Wendy Ren, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Assistant Clinical Professor-Pediatric Anesthesiology

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 29, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 21, 2016
• Results First Posted: October 21, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)