Pediatric Emergence Agitation and PainNCT00932685
Does Distraction With a Hand Held Video Game Reduce Preoperative and Emergence Anxiety in Children?
A study testing Midazolam and Game Boy in people with Pediatric Emergence Agitation and Pain, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
Preoperative anxiety is characterized by subjective feelings of tension, apprehension, nervousness and worry. In children, preoperative anxiety is reported to result in postoperative negative psychological effects, including nightmares, eating problems and increased fear of doctors. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Pediatric Emergence Agitation and Pain
- What is being tested?
- Midazolam and Game Boy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jul 2007
- Phase
- Interventional
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA rating of I-II Mask induction of General Anesthesia
Who cannot join
- Emergency surgery Children who have developmental disabilities or chronic illness Children who have had repetitive surgeries Children who have excessive anxiety attacks or who are currently on benzopaines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Preoperative Distraction With a Hand Held Video Game Boy as Effective as Midazolam in Reducing Preoperative Anxiety Levels in Children as Weel as Emergence Agitation?
Preoperative anxiety is characterized by subjective feelings of tension, apprehension, nervousness and worry. In children, preoperative anxiety is reported to result in postoperative negative psychological effects, including nightmares, eating problems and increased fear of doctors. Previous studies have assessed anxiety in children during the preoperative period and the effects of premedication and parental presence. Midazolzam has been shown to reduce preoperative anxiety in children but post operative recovery maybe delayed for children undergoing a short operative procedure. Distraction may be particularly helpful in children ages 6-12 as these children are curious about their environment. An association between preoperative anxiety and emergence agitation has been suggested. Emergence agitation in children is not well understood but is a frightening experience for child and parent. A previous study demonstrated the efficacy of hand held video games used as an interactive distraction to allay preoperative anxiety. The purpose of this study is to treat preop anxiety with premedication, or video game and to evaluate the impact of these interventions on the incidence and severity of emergence agitation.
- Conditions
- Pediatric Emergence Agitation and Pain
- Being tested
- Midazolam, Game Boy
- Keywords
- pediatric emergence agitation and pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Midazolam 0.5mg/kg
Game BoyDevice
Also called Nintendo-DS Game Boy
Children given video game as a distraction in preop holding and were permitted to continue playing the game in OR during induction
| Study group | Role | What they receive |
|---|---|---|
| 2. Video Game | Active comparator | Not described Receives: Device: Game Boy |
| 1. Midazolam 0.5mg/kg | Active comparator | Not described Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Measured: on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge
Secondary outcomes (1)
emergence agitation
Measured: on arrival, at 5 minutes and every 10 min for one hour in PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startDec 2005
- Primary completionJun 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Emergence Agitation and PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Nintendo of North America
- Investigators
- Anuradha Patel, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932685
- Sponsor's protocol ID
- 0120030315A
- Status last verified
- Jul 2009
- First submitted
- 1 Jul 2009
- Last updated
- 3 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Preoperative Distraction With a Hand Held Video Game Boy as Effective as Midazolam in Reducing Preoperative Anxiety Levels in Children as Weel as Emergence Agitation?
- ClinicalTrials.gov ID
- NCT00932685
- Acronym / sponsor ID
- 0120030315A
- Conditions
- Pediatric Emergence Agitation and Pain
- Keywords
- pediatric emergence agitation and pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- Nintendo of North America
- Study start
- Dec 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 3 Jul 2009 (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.
Preoperative anxiety is characterized by subjective feelings of tension, apprehension, nervousness and worry. In children, preoperative anxiety is reported to result in postoperative negative psychological effects, including nightmares, eating problems and increased fear of doctors. Previous studies have assessed anxiety in children during the preoperative period and the effects of premedication and parental presence. Midazolzam has been shown to reduce preoperative anxiety in children but post operative recovery maybe delayed for children undergoing a short operative procedure. Distraction may be particularly helpful in children ages 6-12 as these children are curious about their environment. An association between preoperative anxiety and emergence agitation has been suggested. Emergence agitation in children is not well understood but is a frightening experience for child and parent. A previous study demonstrated the efficacy of hand held video games used as an interactive distraction to allay preoperative anxiety. The purpose of this study is to treat preop anxiety with premedication, or video game and to evaluate the impact of these interventions on the incidence and severity of emergence agitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2. Video Game | Active comparator | Device: Game Boy |
| 1. Midazolam 0.5mg/kg | Active comparator | Drug: Midazolam |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA rating of I-II Mask induction of General Anesthesia
Key exclusion criteria (1 listed)
- Emergency surgery Children who have developmental disabilities or chronic illness Children who have had repetitive surgeries Children who have excessive anxiety attacks or who are currently on benzopaines
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 |
|---|---|---|
| MidazolamMidazolam 0.5mg/kg | Drug | 1. Midazolam 0.5mg/kg |
| Game BoyAlso: Nintendo-DS Game BoyChildren given video game as a distraction in preop holding and were permitted to continue playing the game in OR during induction | Device | 2. Video Game |
Primary outcome
postoperative pain
Time frame: on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge
1 secondary outcome
emergence agitation
Time frame: on arrival, at 5 minutes and every 10 min for one hour in PACU
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 3 Jul 2009.
Related trials for Pediatric Emergence Agitation and Pain
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
RecruitingPhase 2
Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
Anesthesia, Pediatric Surgery
Not yet recruitingObservational study
Effect of Preoperative Fasting Duration on Postoperative Pain and Emergence Agitation in Pediatric Patients Undergoing Urogenital Surgery
Postoperative Pain, Emergence Delirium
Recruiting
Effect of Opioid-Free vs Opioid-Based Anesthesia on Postoperative Pain and Emergence Agitation in Children Undergoing Cleft Surgery
Cleft Lip Palate, Orofacial Cleft
Not yet recruiting
Auricular Acupressure for Reducing Postoperative Emergence Agitation in Preschool Children
Emergence Agitation
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.
Anuradha Patel, MD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam and Game Boy in people with Pediatric Emergence Agitation and Pain, run by University of Medicine and Dentistry of New Jersey 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 1 inclusion and 1 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 3 Jul 2009. 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.
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?
postoperative pain (time frame: on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to 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 3 Jul 2009.