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Trial record 69 of 1877 for:    Acetaminophen

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

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ClinicalTrials.gov Identifier: NCT01737593
Recruitment Status : Terminated (Interim analysis revealed a negative effect.)
First Posted : November 29, 2012
Results First Posted : October 21, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Wendy Ren, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Emergence Agitation
Pain
Intervention Drug: Acetaminophen
Enrollment 108
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acetaminophen PR Acetaminophen PO-low Dose Acetaminophen PO-high Dose
Hide Arm/Group Description

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

Acetaminophen

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

Acetaminophen

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

Acetaminophen

Period Title: Overall Study
Started 37 32 39
Completed 37 32 39
Not Completed 0 0 0
Arm/Group Title Acetaminophen PR Acetaminophen PO-low Dose Acetaminophen PO-high Dose Total
Hide Arm/Group Description

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

Acetaminophen

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

Acetaminophen

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

Acetaminophen

Total of all reporting groups
Overall Number of Baseline Participants 37 32 39 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 32 participants 39 participants 108 participants
2.08  (1.39) 2.20  (1.58) 2.31  (1.53) 2.23  (1.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 32 participants 39 participants 108 participants
Female
8
  21.6%
12
  37.5%
17
  43.6%
37
  34.3%
Male
29
  78.4%
20
  62.5%
22
  56.4%
71
  65.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 32 participants 39 participants 108 participants
37 32 39 108
1.Primary Outcome
Title Postanesthesia Emergence Agitation (EA) Score
Hide Description

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

Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen by Rectum (PR) Acetaminophen by Mouth (PO) - Low Dose Acetaminophen by Mouth (PO) - High Dose
Hide Arm/Group Description:

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

Acetaminophen

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

Acetaminophen

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

Acetaminophen

Overall Number of Participants Analyzed 37 32 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.63  (3.07) 6.19  (3.53) 6.37  (3.96)
2.Secondary Outcome
Title Postanesthesia Pain Score
Hide Description Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.
Time Frame Induction
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen PR Acetaminophen PO - Low Dose Acetaminophen PO - High Dose
Hide Arm/Group Description:

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

Acetaminophen

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

Acetaminophen

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

Acetaminophen

Overall Number of Participants Analyzed 37 32 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.78  (1.931) 8.66  (2.444) 8.69  (2.307)
3.Secondary Outcome
Title Postanesthesia Pain Score
Hide Description Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.
Time Frame Emergence (spontaneous extremity movement)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen PR Acetaminophen PO - Low Dose Acetaminophen PO - High Dose
Hide Arm/Group Description:

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

Acetaminophen

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

Acetaminophen

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

Acetaminophen

Overall Number of Participants Analyzed 37 32 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.0  (1.780) 8.56  (1.564) 8.79  (1.689)
4.Secondary Outcome
Title Postanesthesia Pain Score
Hide Description Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.
Time Frame 5 minutes post-emergence
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen PR Acetaminophen PO - Low Dose Acetaminophen PO - High Dose
Hide Arm/Group Description:

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

Acetaminophen

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

Acetaminophen

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

Acetaminophen

Overall Number of Participants Analyzed 37 32 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.27  (2.244) 8.41  (1.643) 8.08  (2.044)
5.Secondary Outcome
Title Postanesthesia Pain Score
Hide Description Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.
Time Frame 15 minutes post-emergence
Hide Outcome Measure Data
Hide Analysis Population Description
Participants not yet discharged at the 15 minute time point
Arm/Group Title Acetaminophen PR Acetaminophen PO - Low Dose Acetaminophen PO - High Dose
Hide Arm/Group Description:

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

Acetaminophen

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

Acetaminophen

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

Acetaminophen

Overall Number of Participants Analyzed 36 32 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.83  (1.577) 7.22  (1.518) 7.36  (1.814)
6.Secondary Outcome
Title Postanesthesia Pain Score
Hide Description Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.
Time Frame 30 minutes post-emergence
Hide Outcome Measure Data
Hide Analysis Population Description
Participants not yet discharged at the 30 minute time point
Arm/Group Title Acetaminophen PR Acetaminophen PO - Low Dose Acetaminophen PO - High Dose
Hide Arm/Group Description:

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

Acetaminophen

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

Acetaminophen

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

Acetaminophen

Overall Number of Participants Analyzed 33 27 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.52  (1.278) 6.78  (1.251) 6.42  (1.458)
7.Secondary Outcome
Title Postanesthesia Pain Score
Hide Description Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.
Time Frame 45 minutes post-emergence
Hide Outcome Measure Data
Hide Analysis Population Description
Participants not yet discharged at the 45 minute time point
Arm/Group Title Acetaminophen PR Acetaminophen PO - Low Dose Acetaminophen PO - High Dose
Hide Arm/Group Description:

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

Acetaminophen

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

Acetaminophen

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

Acetaminophen

Overall Number of Participants Analyzed 13 11 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.77  (1.301) 6.18  (0.751) 6.71  (1.326)
8.Secondary Outcome
Title Postanesthesia Pain Score
Hide Description Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.
Time Frame Prior to discharge, up to 3 hours after induction.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen PR Acetaminophen PO - Low Dose Acetaminophen PO - High Dose
Hide Arm/Group Description:

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

Acetaminophen

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

Acetaminophen

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

Acetaminophen

Overall Number of Participants Analyzed 37 32 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.95  (0.848) 6.03  (0.999) 5.92  (1.244)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetaminophen PR Acetaminophen PO-low Dose Acetaminophen PO-high Dose
Hide Arm/Group Description

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

Acetaminophen

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

Acetaminophen

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

Acetaminophen

All-Cause Mortality
Acetaminophen PR Acetaminophen PO-low Dose Acetaminophen PO-high Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Acetaminophen PR Acetaminophen PO-low Dose Acetaminophen PO-high Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/32 (0.00%)   0/39 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acetaminophen PR Acetaminophen PO-low Dose Acetaminophen PO-high Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/32 (0.00%)   0/39 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Wendy Ren
Organization: UCLA
Phone: 310.267.8678
EMail: wren@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Wendy Ren, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01737593     History of Changes
Other Study ID Numbers: 12-001510
First Submitted: November 13, 2012
First Posted: November 29, 2012
Results First Submitted: June 11, 2015
Results First Posted: October 21, 2016
Last Update Posted: October 21, 2016