NCT07410078

Brief Summary

This prospective, three-arm study aims to evaluate the effects of different oral premedication regimens on venipuncture tolerance in pediatric patients undergoing ambulatory surgery. Children aged 4-12 years scheduled for elective day-case procedures will receive oral midazolam alone, midazolam combined with ibuprofen, or midazolam combined with ketamine prior to anesthesia induction. The primary outcome is the proportion of children with well-tolerated venipuncture, assessed using standardized behavioral and pain scales. Secondary outcomes include anxiety levels, venipuncture success parameters, time to successful intravenous access, and parent and anesthesiologist satisfaction. In cases of inadequate premedication or failed venipuncture, a predefined rescue inhalational induction protocol will be applied to ensure patient safety. The study aims to identify clinically effective premedication strategies that may improve cooperation and reduce distress during intravenous cannulation in pediatric ambulatory anesthesia.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Feb 2026Sep 2026

First Submitted

Initial submission to the registry

February 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 19, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2026

Expected
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

February 7, 2026

Last Update Submit

March 3, 2026

Conditions

Pediatric AnesthesiaPremedication

Keywords

Pediatric AnesthesiaPremedicationAmbulatory surgeryVenipuncture toleranceAnxiety

Outcome Measures

Primary Outcomes (1)

  • Proportion of Well-Tolerated Venipuncture

    The proportion of children with well-tolerated venipuncture during intravenous cannulation, assessed using the Children's Fear Scale (CFS), a validated 5-point scale ranging from 0 to 4 (0 = no fear; 4 = extreme fear). Well-tolerated venipuncture is defined as a CFS score \< 3 at the time of the venipuncture attempt.

    During intravenous cannulation in the operating room

Secondary Outcomes (2)

  • Anxiety Scores

    Assessed preoperatively before oral premedication and after premedication in the preoperative holding area.

  • Pain Scores During Venipuncture

    During intravenous cannulation in the operating room

Study Arms (3)

Oral Midazolam Premedication

ACTIVE COMPARATOR

Participants in this arm will receive oral midazolam as premedication at a dose of 0.5 mg/kg (maximum 15 mg), administered approximately 20 minutes before transfer to the operating room. The medications will be administered once prior to anesthesia induction. Venipuncture tolerance, anxiety, and pain-related outcomes will be assessed during intravenous cannulation.

Procedure: Oral Midazolam Premedication

Oral Midazolam plus Ibuprofen Premedication

ACTIVE COMPARATOR

Participants in this arm will receive a combination of oral midazolam at a dose of 0.5 mg/kg (maximum 15 mg) and oral ibuprofen at a dose of 10 mg/kg, administered approximately 20 minutes before transfer to the operating room. The medications will be administered once prior to anesthesia induction. Venipuncture tolerance, anxiety, and pain-related outcomes will be assessed during intravenous cannulation.

Procedure: Oral Midazolam plus Ibuprofen Premedication

Oral Midazolam plus Ketamine Premedication

ACTIVE COMPARATOR

Participants in this arm will receive oral midazolam at a dose of 0.5 mg/kg (maximum 15 mg) combined with oral ketamine at a dose of 3 mg/kg, administered approximately 20 minutes before transfer to the operating room. The medications will be administered once prior to anesthesia induction. Venipuncture tolerance, anxiety, and pain-related outcomes will be assessed during intravenous cannulation.

Procedure: Oral Midazolam plus Ketamine Premedication

Interventions

Oral Midazolam plus Ibuprofen PremedicationPROCEDURE

Participants in this group will receive oral midazolam and oral ibuprofen approximately 20 minutes before transfer to the operating room. Both medications will be administered as a single dose prior to intravenous cannulation. Behavioral and pain-related assessments will be recorded during intravenous cannulation.

Oral Midazolam plus Ibuprofen Premedication
Oral Midazolam plus Ketamine PremedicationPROCEDURE

Participants in this group will receive oral midazolam and oral ketamine approximately 20 minutes before transfer to the operating room. Both medications will be administered as a single dose prior to intravenous cannulation. Behavioral and pain-related assessments will be recorded during intravenous cannulation.

Oral Midazolam plus Ketamine Premedication
Oral Midazolam PremedicationPROCEDURE

Participants in this group will receive oral midazolam approximately 20 minutes before transfer to the operating room. The medication will be administered as a single dose prior to intravenous cannulation. Behavioral and pain-related assessments will be recorded during intravenous cannulation.

Oral Midazolam Premedication

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients aged 4-12 years
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Scheduled for elective ambulatory (day-case) surgery
  • Eligible to receive oral premedication
  • Cognitive ability sufficient to complete behavioral and pain scale assessments
  • Written informed consent obtained from a parent or legal guardian

You may not qualify if:

  • ASA physical status III or higher
  • Moderate to severe intellectual disability
  • Moderate to severe autism spectrum disorder
  • Known allergy or contraindication to midazolam, ketamine, or ibuprofen
  • History of sedative or opioid use within the previous 24 hours
  • Complete loss of premedication due to vomiting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Elif Şule Özdemir Sezgi

CONTACT

00905059209638elifsule-91@hotmail.com

Aslı Dönmez

CONTACT

00905322256473aslidonmez@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 13, 2026

Study Start

February 19, 2026

Primary Completion (Estimated)

August 19, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

TU(1)