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Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery

NCT07340008 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-14

No results posted yet for this study

Summary

This prospective, randomized study is designed to compare the efficacy and safety of three sedative-analgesic agents-intramuscular ketamine, intranasal nalbuphine, and intranasal dexmedetomidine-for procedural sedation in children undergoing suture removal following cleft palate, alveolar ridge, or lip surgery. The study will include 60 children aged 6 months to 3 years, randomly assigned to one of three intervention groups.

The primary objectives are to compare time to achieve adequate sedation (Modified Ramsay Sedation Scale 2-3), surgeon-rated ease of surgical procedure, and time to discharge readiness (Modified Aldrete Score ≥9). Secondary outcomes include baseline child behavior, response to drug administration, depth of sedation, response to separation from parents, and parental satisfaction, as well as monitoring of perioperative complications and vital signs.

All study medications are approved and commonly used in pediatric anesthesia. The trial will be conducted using non-invasive monitoring, with intravenous access established only in case of emergency interventions. Findings from this study are expected to provide evidence to optimize pediatric sedation protocols for minor surgical procedures.

Conditions

  • Orofacial Clefts
  • Cleft Lip and Palate
  • Alveolar Ridge Defect

Interventions

DRUG

ketamine

Intramuscular administration of Ketamine at 4 mg/kg body weight for analgosedation during suture removal in children after surgery for congenital clefts. Glycopyrrolate 4 mcg/kg will be co-administered to reduce salivation.

DRUG

Nalbuphine

Intranasal administration of Nalbuphine at 0.5 mg/kg body weight via mucosal atomizer device (MAD) for analgosedation during suture removal after cleft surgery in children.

DRUG

Dexmedetomidine

Intranasal administration of Dexmedetomidine at 3 mcg/kg body weight via mucosal atomizer device (MAD) for analgosedation during suture removal after cleft surgery in children.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Tadej P Dovšak, DDS, MD, PhD · University Medical Centre Ljubljana, Department of Maxillofacial and Oral Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2028-01-31
Completion
2029-01-31

Countries

  • Slovenia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07340008 on ClinicalTrials.gov