Emergence AgitationLOLLIPOP-EDNCT07571707
Effect of Lollipop on Emergence Delirium in Pediatric Patients Undergoing General Anesthesia
A study testing Lollipop in people with Emergence Agitation, run by Udayana University at 1 site in Indonesia.
Trial summary
This study aims to evaluate the effectiveness of lollipop administration after surgery in reducing emergence agitation in pediatric patients undergoing anesthesia with sevoflurane at RS Ngoerah. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Lollipop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Apr 2026to 30 Jul 2026
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 2-6 years
- Scheduled for elective surgery under general anesthesia with sevoflurane
- American Society of Anesthesiologists (ASA) physical status I-II
- Written informed consent obtained from parents or legal guardians
Who cannot join
- Known allergy or contraindication to study-related procedures
- Developmental delay or neurological disorders affecting behavior assessment
- Use of sedative or psychoactive medications prior to surgery
- History of emergence delirium or significant behavioral disorders
- Intraoperative complications requiring deviation from standard anesthesia protocol
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUP Prof. Dr. I.G.N.G. Ngoerah (Sanglah Hospital)
Denpasar, Bali, 80113
About this study
Official title: Effect of Lollipop on Emergence Delirium in Pediatric Patients Undergoing General Anesthesia: A Randomized Controlled Trial
This study aims to evaluate the effectiveness of lollipop administration after surgery in reducing emergence agitation in pediatric patients undergoing anesthesia with sevoflurane at RS Ngoerah.
Emergence agitation is a common condition in children after general anesthesia, characterized by restlessness, confusion, and distress during recovery. This study investigates whether providing a lollipop as a simple, non-pharmacological intervention can help reduce the incidence and severity of agitation.
Pediatric patients undergoing surgery with sevoflurane anesthesia will be observed postoperatively, and their level of agitation will be assessed using standardized evaluation methods. The results of this study are expected to provide a safe, practical, and easily applicable approach to improve postoperative recovery in children.
Read the detailed description
Emergence agitation is a common postoperative complication in pediatric patients undergoing general anesthesia, particularly with sevoflurane. It is characterized by confusion, restlessness, inconsolable crying, and disorientation during the early recovery period. This condition can lead to self-injury, increased stress for caregivers, and challenges in postoperative management.
Various pharmacological interventions have been used to reduce emergence agitation; however, these may be associated with side effects such as delayed recovery or respiratory depression. Therefore, non-pharmacological approaches that are safe, simple, and effective are needed.
This study aims to evaluate the effectiveness of lollipop administration as a non-pharmacological intervention to reduce emergence agitation in pediatric patients following surgery under sevoflurane anesthesia at RS Ngoerah.
Eligible pediatric patients undergoing surgery with general anesthesia using sevoflurane will be included in this study. After surgery, patients will receive standard postoperative care, and the intervention group will be given a lollipop during the recovery period. The control group will receive standard care without lollipop administration.
The level of emergence agitation will be assessed using a validated scoring system at specified time intervals in the postoperative recovery room. Additional observations may include duration of agitation, need for rescue medication, and recovery profile.
The primary outcome of this study is the difference in the incidence and severity of emergence agitation between the intervention and control groups. Secondary outcomes include recovery time and any adverse events associated with the intervention.
The findings of this study are expected to provide evidence for a simple, safe, and cost-effective method to improve postoperative recovery in pediatric patients.
- Conditions
- Emergence Agitation
- Being tested
- Lollipop
- Keywords
- Pediatric Anesthesia, Sevoflurane, Non pharmacological intervention, lollipop intervention, post operative agitation
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LollipopOther
This study is a prospective, parallel-group, randomized controlled trial. Pediatric patients undergoing surgery under sevoflurane anesthesia will be randomly allocated in a 1:1 ratio to either the intervention group (lollipop administration during the immediate postoperative period) or the control group (standard care).
Randomization will be performed using a computer-generated sequence, with allocation concealment as appropriate. Outcome assessors will evaluate emergence agitation using standardized scales.
The primary endpoint is the incidence and severity of emergence agitation. Secondary endpoints include recovery time and postoperative comfort.
| Study group | Role | What they receive |
|---|---|---|
| Lollipop Group | Experimental | Pediatric patients receiving a lollipop immediately after emergence from anesthesia to reduce emergence agitation Receives: Other: Lollipop |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence agitation measured by PAED scale
Emergence agitation will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Incidence will be defined as a PAED score ≥10, and severity will be recorded as the maximum PAED score observed within the first 30 minutes following emergence from anesthesia.
Measured: 0 to 60 minutes post-emergence from anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start10 Apr 2026
- Primary completion30 Jun 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of two parallel groups: an intervention group receiving a lollipop postoperatively and a control group receiving standard care without a lollipop. The level of emergence agitation will be assessed and compared between the two groups using standardized evaluation methods.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Putu Kurniyanta, Udayana University
- Investigators
- I Putu Kurniyanta, MD, PhD, Sp.An, Principal investigator, Udayana University, Denpasar, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571707
- Sponsor's protocol ID
- UNUD-PAED-2026
- Other IDs
- 2026.02.1.0523
- Acronym
- LOLLIPOP-ED
- Status last verified
- Oct 2026
- First submitted
- 19 Apr 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared, including demographic characteristics (age, sex), intraoperative variables, and outcome data related to emergence agitation (incidence and severity scores), recovery time, and postoperative comfort. Data will be available to qualified researchers upon reasonable request to the corresponding author, following publication of the study results. Access will be granted to researchers who provide a methodologically sound proposal, subject to approval by the study investigators and in accordance with institutional and ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lollipop on Emergence Delirium in Pediatric Patients Undergoing General Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07571707
- Acronym / sponsor ID
- LOLLIPOP-ED / UNUD-PAED-2026
- Conditions
- Emergence Agitation
- Keywords
- Pediatric Anesthesia, Sevoflurane, Non pharmacological intervention, lollipop intervention, post operative agitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 6 May 2026 (actual)
- 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.
This study aims to evaluate the effectiveness of lollipop administration after surgery in reducing emergence agitation in pediatric patients undergoing anesthesia with sevoflurane at RS Ngoerah.
Emergence agitation is a common condition in children after general anesthesia, characterized by restlessness, confusion, and distress during recovery. This study investigates whether providing a lollipop as a simple, non-pharmacological intervention can help reduce the incidence and severity of agitation.
Pediatric patients undergoing surgery with sevoflurane anesthesia will be observed postoperatively, and their level of agitation will be assessed using standardized evaluation methods. The results of this study are expected to provide a safe, practical, and easily applicable approach to improve postoperative recovery in children.
Detailed description
Emergence agitation is a common postoperative complication in pediatric patients undergoing general anesthesia, particularly with sevoflurane. It is characterized by confusion, restlessness, inconsolable crying, and disorientation during the early recovery period. This condition can lead to self-injury, increased stress for caregivers, and challenges in postoperative management.
Various pharmacological interventions have been used to reduce emergence agitation; however, these may be associated with side effects such as delayed recovery or respiratory depression. Therefore, non-pharmacological approaches that are safe, simple, and effective are needed.
This study aims to evaluate the effectiveness of lollipop administration as a non-pharmacological intervention to reduce emergence agitation in pediatric patients following surgery under sevoflurane anesthesia at RS Ngoerah.
Eligible pediatric patients undergoing surgery with general anesthesia using sevoflurane will be included in this study. After surgery, patients will receive standard postoperative care, and the intervention group will be given a lollipop during the recovery period. The control group will receive standard care without lollipop administration.
The level of emergence agitation will be assessed using a validated scoring system at specified time intervals in the postoperative recovery room. Additional observations may include duration of agitation, need for rescue medication, and recovery profile.
The primary outcome of this study is the difference in the incidence and severity of emergence agitation between the intervention and control groups. Secondary outcomes include recovery time and any adverse events associated with the intervention.
The findings of this study are expected to provide evidence for a simple, safe, and cost-effective method to improve postoperative recovery in pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of two parallel groups: an intervention group receiving a lollipop postoperatively and a control group receiving standard care without a lollipop. The level of emergence agitation will be assessed and compared between the two groups using standardized evaluation methods.
| Arm | Type | Receives |
|---|---|---|
| Lollipop Group | Experimental | Other: LollipopPediatric patients receiving a lollipop immediately after emergence from anesthesia to reduce emergence agitation |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients aged 2-6 years
- Scheduled for elective surgery under general anesthesia with sevoflurane
- American Society of Anesthesiologists (ASA) physical status I-II
- Written informed consent obtained from parents or legal guardians
Key exclusion criteria (5 listed)
- Known allergy or contraindication to study-related procedures
- Developmental delay or neurological disorders affecting behavior assessment
- Use of sedative or psychoactive medications prior to surgery
- History of emergence delirium or significant behavioral disorders
- Intraoperative complications requiring deviation from standard anesthesia protocol
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 |
|---|---|---|
| LollipopThis study is a prospective, parallel-group, randomized controlled trial. Pediatric patients undergoing surgery under sevoflurane anesthesia will be randomly allocated in a 1:1 ratio to either the intervention group (lollipop administration during the immediate postoperative period) or the control group (standard care). Randomization will be performed using a computer-generated sequence, with allocation concealment as appropriate. Outcome assessors will evaluate emergence agitation using standardized scales. The primary endpoint is the incidence and severity of emergence agitation. Secondary endpoints include recovery time and postoperative comfort. | Other | Lollipop Group |
Primary outcome
Emergence agitation measured by PAED scale
Time frame: 0 to 60 minutes post-emergence from anesthesia
Emergence agitation will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Incidence will be defined as a PAED score ≥10, and severity will be recorded as the maximum PAED score observed within the first 30 minutes following emergence from anesthesia.
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 29 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared, including demographic characteristics (age, sex), intraoperative variables, and outcome data related to emergence agitation (incidence and severity scores), recovery time, and postoperative comfort. Data will be available to qualified researchers upon reasonable request to the corresponding author, following publication of the study results. Access will be granted to researchers who provide a methodologically sound proposal, subject to approval by the study investigators and in accordance with institutional and ethical regulations.
Related trials for Emergence Agitation
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Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
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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.
I Putu Kurniyanta, MD, PhD, Sp.An principal investigator
Udayana University, Denpasar, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lollipop in people with Emergence Agitation, run by Udayana University at 1 site in Indonesia.
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 4 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 29 Oct 2026. 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 Indonesia. 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?
Emergence agitation measured by PAED scale (time frame: 0 to 60 minutes post-emergence from anesthesia). 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 29 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.