Trial Outcomes & Findings for Can Acetaminophen Given 1-2 Hours to Children Before Ear Tube Surgery Reduce Agitation After Anesthesia? (NCT NCT01737593)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

108 participants

Primary outcome timeframe

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.

Results posted on

2016-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Acetaminophen PR Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally) Acetaminophen	Acetaminophen PO-low Dose Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen	Acetaminophen PO-high Dose Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen
Overall Study STARTED	37	32	39
Overall Study COMPLETED	37	32	39
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acetaminophen PR n=37 Participants Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally) Acetaminophen	Acetaminophen PO-low Dose n=32 Participants Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen	Acetaminophen PO-high Dose n=39 Participants Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen	Total n=108 Participants Total of all reporting groups
Age, Continuous	2.08 years STANDARD_DEVIATION 1.39 • n=5 Participants	2.20 years STANDARD_DEVIATION 1.58 • n=7 Participants	2.31 years STANDARD_DEVIATION 1.53 • n=5 Participants	2.23 years STANDARD_DEVIATION 1.49 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	20 Participants n=7 Participants	22 Participants n=5 Participants	71 Participants n=4 Participants
Region of Enrollment United States	37 participants n=5 Participants	32 participants n=7 Participants	39 participants n=5 Participants	108 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Acetaminophen by Rectum (PR) n=37 Participants Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally) Acetaminophen	Acetaminophen by Mouth (PO) - Low Dose n=32 Participants Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen	Acetaminophen by Mouth (PO) - High Dose n=39 Participants Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen
Postanesthesia Emergence Agitation (EA) Score	5.63 units on a scale Standard Deviation 3.07	6.19 units on a scale Standard Deviation 3.53	6.37 units on a scale Standard Deviation 3.96

SECONDARY outcome

Timeframe: Induction

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.

Outcome measures

Outcome measures
Measure	Acetaminophen by Rectum (PR) n=37 Participants Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally) Acetaminophen	Acetaminophen by Mouth (PO) - Low Dose n=32 Participants Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen	Acetaminophen by Mouth (PO) - High Dose n=39 Participants Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen
Postanesthesia Pain Score	7.78 units on a scale Standard Deviation 1.931	8.66 units on a scale Standard Deviation 2.444	8.69 units on a scale Standard Deviation 2.307

SECONDARY outcome

Timeframe: Emergence (spontaneous extremity movement)

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.

Outcome measures

Outcome measures
Measure	Acetaminophen by Rectum (PR) n=37 Participants Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally) Acetaminophen	Acetaminophen by Mouth (PO) - Low Dose n=32 Participants Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen	Acetaminophen by Mouth (PO) - High Dose n=39 Participants Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen
Postanesthesia Pain Score	9.0 units on a scale Standard Deviation 1.780	8.56 units on a scale Standard Deviation 1.564	8.79 units on a scale Standard Deviation 1.689

SECONDARY outcome

Timeframe: 5 minutes post-emergence

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.

Outcome measures

Outcome measures
Measure	Acetaminophen by Rectum (PR) n=37 Participants Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally) Acetaminophen	Acetaminophen by Mouth (PO) - Low Dose n=32 Participants Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen	Acetaminophen by Mouth (PO) - High Dose n=39 Participants Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen
Postanesthesia Pain Score	8.27 units on a scale Standard Deviation 2.244	8.41 units on a scale Standard Deviation 1.643	8.08 units on a scale Standard Deviation 2.044

SECONDARY outcome

Timeframe: 15 minutes post-emergence

Population: Participants not yet discharged at the 15 minute time point

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.

Outcome measures

Outcome measures
Measure	Acetaminophen by Rectum (PR) n=36 Participants Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally) Acetaminophen	Acetaminophen by Mouth (PO) - Low Dose n=32 Participants Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen	Acetaminophen by Mouth (PO) - High Dose n=39 Participants Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen
Postanesthesia Pain Score	6.83 units on a scale Standard Deviation 1.577	7.22 units on a scale Standard Deviation 1.518	7.36 units on a scale Standard Deviation 1.814

SECONDARY outcome

Timeframe: 30 minutes post-emergence

Population: Participants not yet discharged at the 30 minute time point

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.

Outcome measures

Outcome measures
Measure	Acetaminophen by Rectum (PR) n=33 Participants Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally) Acetaminophen	Acetaminophen by Mouth (PO) - Low Dose n=27 Participants Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen	Acetaminophen by Mouth (PO) - High Dose n=33 Participants Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen
Postanesthesia Pain Score	6.52 units on a scale Standard Deviation 1.278	6.78 units on a scale Standard Deviation 1.251	6.42 units on a scale Standard Deviation 1.458

SECONDARY outcome

Timeframe: 45 minutes post-emergence

Population: Participants not yet discharged at the 45 minute time point

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.

Outcome measures

Outcome measures
Measure	Acetaminophen by Rectum (PR) n=13 Participants Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally) Acetaminophen	Acetaminophen by Mouth (PO) - Low Dose n=11 Participants Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen	Acetaminophen by Mouth (PO) - High Dose n=14 Participants Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen
Postanesthesia Pain Score	6.77 units on a scale Standard Deviation 1.301	6.18 units on a scale Standard Deviation 0.751	6.71 units on a scale Standard Deviation 1.326

SECONDARY outcome

Timeframe: Prior to discharge, up to 3 hours after induction.

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.

Outcome measures

Outcome measures
Measure	Acetaminophen by Rectum (PR) n=37 Participants Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally) Acetaminophen	Acetaminophen by Mouth (PO) - Low Dose n=32 Participants Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen	Acetaminophen by Mouth (PO) - High Dose n=39 Participants Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) Acetaminophen
Postanesthesia Pain Score	5.95 units on a scale Standard Deviation 0.848	6.03 units on a scale Standard Deviation 0.999	5.92 units on a scale Standard Deviation 1.244

Adverse Events

Acetaminophen PR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acetaminophen PO-low Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acetaminophen PO-high Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Wendy Ren

UCLA

Phone: 310.267.8678

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place