N/A Completed N=114

Relationship Between Preoperative Anxiety, Postoperative Pain, and Emergence Delirium in Pediatric Surgery

Postoperative Pain · Anxiety · Emergence Delirium in Pediatric Anesthesia · Urogenital Diseases

Source: ClinicalTrials.gov NCT07343388 ↗

Enrolled (actual)

114

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcomePrimary: Postoperative Pain Intensity — 1; 1; 3; 1 score

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Postoperative Pain Intensity	1; 1; 3; 1; 0; 0	—
PRIMARY Incidence and Severity of Emergence Delirium	12; 10; 7; 5.5; 3.5; 0	—
SECONDARY Postoperative Physical Recovery and Discharge Readiness	8; 8; 10; 10; 10; 10	—

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT07343388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.