Ignite Creation Date:
2024-05-06 @ 1:06 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01737593
Status:
TERMINATED
Last Update Posted:
2016-10-21
First Post:
2012-11-13
Brief Title:
Can Acetaminophen Given 1-2 Hours to Children Before Ear Tube Surgery Reduce Agitation After Anesthesia
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Can Acetaminophen PO Given 1-2 Hours Before Bilateral Myringotomy Tube BMT Placement Reduce Emergence Agitation EA in Children After General Sevoflurane Anesthesia
Status:
TERMINATED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis revealed a negative effect
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgkg at 60-120 minutes prior to surgery Group 2 will receive acetaminophen 20 mgkg 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
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 mgkg at 60-120 minutes prior to surgery Group 2 will receive acetaminophen 20 mgkg 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
Detailed Description:
Emergence agitation EA occurs in up to 67 of patients undergoing Sevoflurane anesthesia for bilateral myringotomy tube placement BMT Often EA presents as inconsolable screaming crying thrashing and kicking and may require restraints It can be dangerous for the patient because it may be difficult to monitor their vital signs during a critical phase of recovery ie unable to detect hypoxemia they may injure themselves as they thrash about it usually requires the presence of extra staff and it can be very distressing to the parents Causes of EA are theoretical but can be exacerbated by pain 70 of patients undergoing BMT have pain requiring treatment Since BMT is performed without IV placement the options for analgesia are limited to intranasal fentanyl intramuscular ketorolac rectal or oral acetaminophen oral opioids ie codeine oxycodone Intranasal Fentanyl has been shown to decrease EA but results in post operative nausea and vomiting as with any opioids Intramuscular ketorolac is costly and can lead to hematomas In previous studies common practice acetaminophen is given either 30 minutes before induction PO route or immediately after induction PR route Since the procedure is generally completed in 5-10 minutes the therapeutic effect of acetaminophen can not be appreciated The peak effect for analgesia of acetaminophen is 60-120 minutes Our hypothesis If acetaminophen is given 60-120 minutes prior to emergence when it reaches therapeutic effect it can decrease EA in patients undergoing BMT The importance of mitigating EA not only involves patient safety and satisfaction but will also impact hospitalsurgery center efficiency RN staffing and smoother and shorter recovery periods
This study will be a randomized controlled trial Potential subjects will be identified and recruited by study personnel andor patients surgeon Children scheduled for BMT placement whose parents consent to participate will be enrolled in the study These patients will be consented on the day of surgery Parents will be informed that whether they enroll their children in the study or not they will be receiving standard clinical care Only subjects meeting all inclusion criteria and requirements for continuation in the study will be consented
Patients will be enrolled into one of three study groups All patients meeting all inclusion criteria and requirements for the study see below will be identified consented then computer randomized into either control group 1 or 2
Control - acetaminophen PR 20-40mgkg after induction of Anesthesia acetaminophen is in suppository form and given rectally Group 1 - acetaminophen PO 10mgkg 60-120min before start of BMT placement acetaminophen is in syrup form and given by mouth Group 2 - acetaminophen PO 20mgkg 60-120min before start of BMT placement acetaminophen is in syrup form and given by mouth
After randomization treating physicians will be made aware of what treatment group the patient is assigned to The data collection and behaviorpain assessments will be made by blinded study personnel in the operating room only for induction and PACU
Data Collection Data will be collected at the time points Induction Emergence spontaneous extremity movement and every 5 minutes after emergence until the patient is discharged There will also be a follow-up questionnaire for the parent on satisfaction with the childs emergence side effects additional medications and hisher PACU experience This will be conducted on the phone within 36 hours after the parents have left the hospital
This study will be a randomized controlled trial Potential subjects will be identified and recruited by study personnel andor patients surgeon Children scheduled for BMT placement whose parents consent to participate will be enrolled in the study These patients will be consented on the day of surgery Parents will be informed that whether they enroll their children in the study or not they will be receiving standard clinical care Only subjects meeting all inclusion criteria and requirements for continuation in the study will be consented
Patients will be enrolled into one of three study groups All patients meeting all inclusion criteria and requirements for the study see below will be identified consented then computer randomized into either control group 1 or 2
Control - acetaminophen PR 20-40mgkg after induction of Anesthesia acetaminophen is in suppository form and given rectally Group 1 - acetaminophen PO 10mgkg 60-120min before start of BMT placement acetaminophen is in syrup form and given by mouth Group 2 - acetaminophen PO 20mgkg 60-120min before start of BMT placement acetaminophen is in syrup form and given by mouth
After randomization treating physicians will be made aware of what treatment group the patient is assigned to The data collection and behaviorpain assessments will be made by blinded study personnel in the operating room only for induction and PACU
Data Collection Data will be collected at the time points Induction Emergence spontaneous extremity movement and every 5 minutes after emergence until the patient is discharged There will also be a follow-up questionnaire for the parent on satisfaction with the childs emergence side effects additional medications and hisher PACU experience This will be conducted on the phone within 36 hours after the parents have left the hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None