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| ID | Type | Description | Link |
|---|---|---|---|
| 2026.02.1.0523 | Other Identifier | Ethics Committee Faculty of Medicine, Universitas Udayana |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lollipop Group | Experimental | Pediatric patients receiving a lollipop immediately after emergence from anesthesia to reduce emergence agitation |
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| Control Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lollipop | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 to 60 minutes post-emergence from anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| I Putu Kurniyanta, MD, PhD, Sp.An-TI | Contact | +628113800121 | antasari.2271101003@student.unud.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| I Putu Kurniyanta, MD, PhD, Sp.An | Udayana University, Denpasar, Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUP Prof. Dr. I.G.N.G. Ngoerah (Sanglah Hospital) | Recruiting | Denpasar | Bali | 80113 | Indonesia |
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.
Data will be available beginning 3 months following publication of the study results and will remain available for a period of 5 years.
Access to de-identified individual participant data (IPD) and supporting documents will be provided to qualified researchers who submit a methodologically sound research proposal. Requests should be directed to the corresponding author. Data will be shared after approval by the study investigators and in accordance with institutional policies and ethical regulations. A data use agreement may be required prior to data access.
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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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.
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Outcome assessors will be blinded to group allocation. Due to the nature of the intervention, participants and care providers cannot be blinded.
|
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |