Emergence Delirium in Pediatric Anesthesia, Postoperative Pain, Preoperative Anxiety, Urogenital Diseases
Conditions
Keywords
preoperative anxiety, postoperative pain, Postoperative Complications, mYPAS, FLACC Scale, Aldrete Score, PAED Scale
Brief summary
The goal of this observational study is to learn if preoperative anxiety levels can predict the quality of early postoperative recovery, pain intensity, and the occurrence of emergence delirium in pediatric patients aged 2 to 7 years undergoing elective urogenital surgery, specifically hypospadias repair, orchidopexy, and hydrocele surgery. The main questions it aims to answer are: Does a higher level of preoperative anxiety lead to increased postoperative pain and a higher incidence of emergence delirium? Is there a significant relationship between preoperative anxiety and the speed of physical recovery (discharge readiness) as measured by Aldrete scores? Researchers will compare outcomes of patients with different levels of preoperative anxiety to see if higher anxiety results in poorer recovery profiles in the immediate postoperative period. Participants will: Be assessed for anxiety levels using the Modified Yale Preoperative Anxiety Scale (mYPAS) immediately before anesthesia induction. Undergo a standardized anesthesia protocol for their elective urogenital procedure (hypospadias repair, orchidopexy, or hydrocele surgery). Be monitored in the Post-Anesthesia Care Unit (PACU) at 0, 15, 30, 45, and 60 minutes after surgery to evaluate physical recovery (Modified Aldrete Score), delirium (PAED scale), and pain intensity (FLACC scale).
Interventions
OTHERStandardized Perioperative Management and Observational Assessment
All participants will undergo a standardized general anesthesia protocol for elective urogenital surgery (hypospadias repair, orchidopexy, or hydrocele surgery). The intervention includes: Preoperative Phase: Assessment of anxiety using the mYPAS scale before induction. Intraoperative Phase: Standardized induction and maintenance of anesthesia (e.g., inhalational anesthesia with sevoflurane). Postoperative Phase: Systematic observation in the Post-Anesthesia Care Unit (PACU) using Modified Aldrete, PAED, and FLACC scales at 0, 15, 30, 45, and 60 minutes. No experimental drugs or techniques will be administered; the study focuses on the observational correlation between preoperative anxiety and recovery outcomes."
Sponsors
Aydin Adnan Menderes University
Dr. Behcet Uz Children's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
2 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
Male patients aged 2 to 7 years. ASA (American Society of Anesthesiologists) physical status I or II. Scheduled for elective urogenital surgery, specifically hypospadias repair, orchidopexy, or hydrocele surgery. Scheduled to undergo general anesthesia for the procedure. Patients with no history of neurological or psychiatric disorders. Provision of written informed consent by the parents or legal guardians.
Exclusion criteria
* Patients outside the specified age range (younger than 2 or older than 7 years). Female patients. Patients undergoing emergency surgeries or non-urogenital/non-inguinal procedures. Presence of a diagnosed cognitive impairment or developmental delay. Parental or legal guardian refusal to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | Postoperatively at 0, 15, 30, 45, and 60 minutes. | Measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. This behavioral scale assesses pain in children who cannot communicate verbally. Each of the five categories is scored from 0 to 2, resulting in a total score ranging from 0 to 10. Higher scores indicate increased pain intensity (0: Relaxed/Comfortable, 1-3: Mild discomfort, 4-6: Moderate pain, 7-10: Severe pain/discomfort). |
| Incidence and Severity of Emergence Delirium | Postoperatively at 0, 15, 30, 45, and 60 minutes. | Measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale consists of five items: eye contact, purposeful actions, awareness of surroundings, restlessness, and inconsolability. The total score ranges from 0 to 20, where higher scores indicate greater severity of delirium. A score of 10 or higher is considered clinically significant for the presence of emergence delirium. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Physical Recovery and Discharge Readiness | Postoperatively at 0, 15, 30, 45, and 60 minutes. | Measured using the Modified Aldrete Score, which evaluates five criteria: activity, respiration, circulation, consciousness, and oxygen saturation. Each criterion is scored 0, 1, or 2. The total score ranges from 0 to 10. Higher scores indicate better physical recovery and greater readiness for discharge from the Post-Anesthesia Care Unit (PACU). A score of 9 or 10 is typically required for safe discharge. |
Countries
Turkey (Türkiye)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 4.68 Years STANDARD_DEVIATION 1.85 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 64 |
| other Total, other adverse events | 0 / 50 | 0 / 64 |
| serious Total, serious adverse events | 0 / 50 | 0 / 64 |
Outcome results
None listed