Can Acetaminophen Given 1-2 Hours to Children Before Ear Tube Surgery Reduce Agitation After Anesthesia?
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Neurology |
| Therapuetic Areas: | Musculoskeletal, Neurology |
| Healthy: | No |
| Age Range: | Any - 6 |
| Updated: | 2/7/2015 |
| Start Date: | November 2012 |
| End Date: | October 2013 |
| Contact: | Wendy Ren, MD |
| Email: | wren@mednet.ucla.edu |
| Phone: | 310-267-8693 |
Can Acetaminophen PO Given 1-2 Hours Before Bilateral Myringotomy Tube (BMT) Placement Reduce Emergence Agitation (EA) in Children After General Sevoflurane Anesthesia?
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.
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.
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 (i.e. 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 (i.e. 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 hospital/surgery 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 and/or patient's 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 (20-40mg/kg) after induction of Anesthesia (acetaminophen is in
suppository form and given rectally) Group 1 - acetaminophen PO (10mg/kg) 60-120min before
start of BMT placement (acetaminophen is in syrup form and given by mouth) Group 2 -
acetaminophen PO (20mg/kg) 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 behavior/pain 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 child's emergence, side effects, additional medications, and his/her PACU experience.
This will be conducted on the phone within 36 hours after the parents have left the
hospital.
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 (i.e. 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 (i.e. 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 hospital/surgery 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 and/or patient's 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 (20-40mg/kg) after induction of Anesthesia (acetaminophen is in
suppository form and given rectally) Group 1 - acetaminophen PO (10mg/kg) 60-120min before
start of BMT placement (acetaminophen is in syrup form and given by mouth) Group 2 -
acetaminophen PO (20mg/kg) 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 behavior/pain 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 child's emergence, side effects, additional medications, and his/her PACU experience.
This will be conducted on the phone within 36 hours after the parents have left the
hospital.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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