Emergence AgitationPhase 4NCT01737593
Can Acetaminophen Given 1-2 Hours to Children Before Ear Tube Surgery Reduce Agitation After Anesthesia?
A Phase 4 study testing Acetaminophen in people with Emergence Agitation and Pain, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Agitation, Pain
- What is being tested?
- Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Apr 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles Medical Center
Los Angeles, California, 90095
About this study
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?
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.
Read the 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 (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.
- Conditions
- Emergence Agitation, Pain
- Being tested
- Acetaminophen
- Keywords
- acetaminophen, emergence agitation, children, sevoflurane
- Medical subject headings
- Emergence Delirium, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Tylenol
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen PR | Active comparator | Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally) Receives: 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) Receives: 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) Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: Induction
Postanesthesia Pain Score
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.
Measured: Emergence (spontaneous extremity movement)
Postanesthesia Pain Score
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.
Measured: 5 minutes post-emergence
Postanesthesia Pain Score
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.
Measured: 15 minutes post-emergence
Postanesthesia Pain Score
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.
Measured: 30 minutes post-emergence
Postanesthesia Pain Score
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.
Measured: 45 minutes post-emergence
Postanesthesia Pain Score
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.
Measured: Prior to discharge, up to 3 hours after induction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Interim analysis revealed a negative effect.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Ren, University of California, Los Angeles
- Investigators
- Wendy Ren, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737593
- Sponsor's protocol ID
- 12-001510
- Status last verified
- Aug 2016
- First submitted
- 13 Nov 2012
- Last updated
- 21 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT01737593
- Acronym / sponsor ID
- 12-001510
- Conditions
- Emergence Agitation, Pain
- Keywords
- acetaminophen, emergence agitation, children, sevoflurane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis revealed a negative effect.
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Posted 21 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen PR | Active comparator | Drug: AcetaminophenAcetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally) |
| Acetaminophen PO-low dose | Active comparator | Drug: AcetaminophenAcetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) |
| Acetaminophen PO-high dose | Active comparator | Drug: AcetaminophenAcetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth) |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenAlso: Tylenol | Drug | Acetaminophen PO-high dose, Acetaminophen PO-low dose, Acetaminophen PR |
Primary outcome
Postanesthesia Emergence Agitation (EA) Score
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.
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
7 secondary outcomes
Postanesthesia Pain Score
Time frame: Induction
Postanesthesia Pain Score
Time frame: Emergence (spontaneous extremity movement)
Postanesthesia Pain Score
Time frame: 5 minutes post-emergence
Postanesthesia Pain Score
Time frame: 15 minutes post-emergence
Postanesthesia Pain Score
Time frame: 30 minutes post-emergence
Postanesthesia Pain Score
Time frame: 45 minutes post-emergence
Postanesthesia Pain Score
Time frame: Prior to discharge, up to 3 hours after induction.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Ren, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen in people with Emergence Agitation and Pain, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postanesthesia Emergence Agitation (EA) Score (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.