Emergence DeliriumNCT02980549
How Common Are Sleep Disorders and Problems With Emergence From Anesthesia in Surgical Patients
An observational study of Emergence Delirium and Parasomnias, run by University of Wisconsin, Madison.
Trial summary
Emergence delirium (ED), also called emergence agitation or post-anesthetic excitement, is defined as a dissociated state of consciousness, occurring on awakening from general anesthesia, in which children exhibit psychomotor agitation, crying and thrashing and are not consolable for a period of time, usually 5-15… Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Emergence Delirium, Parasomnias
- What is being tested?
- children's sleep habits questionnaire
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: One hundred children age 1-6, ASA PS I or II, undergoing surgery by either elective otolaryngology (ENT) (including but not limited to: tonsillectomy, adenoidectomy, and lymph node biopsy) or elective urologic surgery (including but not limited to: circumcision, cystoscopy and related procedures, orchidopexy or hernia), requiring intravenous line placement, at American Family children's Hospital at the University of Wisconsin will be enrolled in the study. The child's caregiver will complete a sleep questionnaire prior to anesthesia and surgery. From the time the anesthetic is discontinued, after surgery, a study coordinator will observe the child's emergence from anesthesia and rate emergence using the PAED scale every 5 minutes until the child is awake.
Who may be able to join
- Pediatric patients age 1-6 (inclusive) scheduled for elective ENT or urologic surgery
- ASA I or II
- Presence of a caregiver who is familiar with the child's sleep history
Who cannot join
- Autism
- Severe developmental delay
- Children receiving clonidine
- Medication for seizures
- Children who have received ED treatment prior to a diagnosis of ED (clonidine, dexmedetomidine, or propofol)
About this study
Official title: Determining the Incidence of Parasomnias (PS) and Emergence Delirium (ED)in the American Family Children's Hospital Patient Population
Emergence delirium (ED), also called emergence agitation or post-anesthetic excitement, is defined as a dissociated state of consciousness, occurring on awakening from general anesthesia, in which children exhibit psychomotor agitation, crying and thrashing and are not consolable for a period of time, usually 5-15 minutes. Emergence delirium is a common problem in pre-school children, with estimates of the incidence ranging from 10-70% of children in this age group. These children are agitated, seemingly unaware of their surroundings, and typically do not respond to parents or caregivers. They are therefore at risk for self-inflicted traumatic injury and complications secondary to disruptions of intravenous lines, surgical incisions, or drains. Children with ED typically require more resources in the postoperative period than children who do not exhibit ED. Predicting the likelihood of ED would allow for better allocation of resources in the post-anesthetic care unit (PACU).
The peak incidence of ED in children occurs in the same age range at which the peak incidence of parasomnias (PS) occurs. The description of parasomnias is strikingly similar to the description of ED; the American Academy of Sleep Medicine defines parasomnias as "undesirable physical events or experiences that occur during entry into sleep, within sleep or during arousals from sleep." Parasomnias can be diagnosed using a sleep questionnaire.
The purpose of this pilot study is to determine the incidence of ED and PS in our population, in order to determine the number of patients necessary to enroll in a larger study to either confirm or reject the hypothesis that ED and PS are correlated.
- Conditions
- Emergence Delirium, Parasomnias
- Being tested
- children's sleep habits questionnaire
- Medical subject headings
- Emergence Delirium, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
children's sleep habits questionnaireOther
survey of children's sleep habits completed by parent
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of parasomnias (PS) and emergence delirium (ED) in children
Measured: 6 months
Secondary outcomes (1)
score on Childrens Sleep Habits Questionnaire correlated with ED
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980549
- Sponsor's protocol ID
- 2015-0116
- Status last verified
- Nov 2016
- First submitted
- 5 May 2015
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Incidence of Parasomnias (PS) and Emergence Delirium (ED)in the American Family Children's Hospital Patient Population
- ClinicalTrials.gov ID
- NCT02980549
- Acronym / sponsor ID
- 2015-0116
- Conditions
- Emergence Delirium, Parasomnias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Emergence delirium (ED), also called emergence agitation or post-anesthetic excitement, is defined as a dissociated state of consciousness, occurring on awakening from general anesthesia, in which children exhibit psychomotor agitation, crying and thrashing and are not consolable for a period of time, usually 5-15 minutes. Emergence delirium is a common problem in pre-school children, with estimates of the incidence ranging from 10-70% of children in this age group. These children are agitated, seemingly unaware of their surroundings, and typically do not respond to parents or caregivers. They are therefore at risk for self-inflicted traumatic injury and complications secondary to disruptions of intravenous lines, surgical incisions, or drains. Children with ED typically require more resources in the postoperative period than children who do not exhibit ED. Predicting the likelihood of ED would allow for better allocation of resources in the post-anesthetic care unit (PACU).
The peak incidence of ED in children occurs in the same age range at which the peak incidence of parasomnias (PS) occurs. The description of parasomnias is strikingly similar to the description of ED; the American Academy of Sleep Medicine defines parasomnias as "undesirable physical events or experiences that occur during entry into sleep, within sleep or during arousals from sleep." Parasomnias can be diagnosed using a sleep questionnaire.
The purpose of this pilot study is to determine the incidence of ED and PS in our population, in order to determine the number of patients necessary to enroll in a larger study to either confirm or reject the hypothesis that ED and PS are correlated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- One hundred children age 1-6, ASA PS I or II, undergoing surgery by either elective otolaryngology (ENT) (including but not limited to: tonsillectomy, adenoidectomy, and lymph node biopsy) or elective urologic surgery (including but not limited to: circumcision, cystoscopy and related procedures, orchidopexy or hernia), requiring intravenous line placement, at American Family children's Hospital at the University of Wisconsin will be enrolled in the study. The child's caregiver will complete a sleep questionnaire prior to anesthesia and surgery. From the time the anesthetic is discontinued, after surgery, a study coordinator will observe the child's emergence from anesthesia and rate emergence using the PAED scale every 5 minutes until the child is awake.
Key inclusion criteria (3 listed)
- Pediatric patients age 1-6 (inclusive) scheduled for elective ENT or urologic surgery
- ASA I or II
- Presence of a caregiver who is familiar with the child's sleep history
Key exclusion criteria (5 listed)
- Autism
- Severe developmental delay
- Children receiving clonidine
- Medication for seizures
- Children who have received ED treatment prior to a diagnosis of ED (clonidine, dexmedetomidine, or propofol)
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 |
|---|---|---|
| children's sleep habits questionnairesurvey of children's sleep habits completed by parent | Other | – |
Primary outcome
Prevalence of parasomnias (PS) and emergence delirium (ED) in children
Time frame: 6 months
1 secondary outcome
score on Childrens Sleep Habits Questionnaire correlated with ED
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence Delirium and Parasomnias, run by University of Wisconsin, Madison.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of parasomnias (PS) and emergence delirium (ED) in children (time frame: 6 months). 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 2 Dec 2016; AzTrials last refreshed its copy on 31 Oct 2026.