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

NCT07340008 | Recruiting

• 2 other identifiers: UKCLJ-KID-CLEFT-TP 20240163TP 20240163
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pediatric sedation; Cleft surgery; Ketamine; Dexmedetomidine; Nalbuphine; Intranasal sedation; Intramuscular injection; Sedation in children

Outcome Measures

Primary Outcomes (5)

• Time to achieve adequate sedation (Modified Ramsay Sedation Score 2-3)

  Time in minutes from administration of the study drug until the child reaches adequate sedation, defined as a Ramsay Sedation Score of 2-3. Sedation is assessed every 5 minutes by a trained clinician. Unit of Measure: Minutes

  Perioperatively, from drug administration until Modified Ramsay score 2-3 is achieved (typically within 5-20 minutes)

• Sedation depth before procedure (Modified Ramsay Sedation Scale)

  Sedation depth is measured using the Modified Ramsay Sedation Scale (1 = anxious/agitated, 6 = no response; 2-3 = adequate sedation). A trained clinician assesses sedation every 5 minutes after administration of the study drug, until the start of the suture removal procedure.

  Periprocedural (every 5 minutes for up to 20 minutes after study drug administration, until procedure begins)

• Surgeon-rated ease of surgical procedure

  Ease of suture removal as rated by the operating surgeon using a 5-point Likert scale (1 = very difficult, 5 = very easy). Unit of measure: Units on a scale

  Within 5 minutes after completion of suture removal

• Time to discharge from recovery room

  Time in minutes from the end of the surgical procedure until the child reaches a Modified Aldrete Score of ≥9, indicating readiness for discharge from the recovery area to the hospital ward. The Aldrete score is assessed every 5 minutes by recovery room nursing staff. Unit of Measure: Minutes

  Perioperative (every 5 minutes post-procedure until Modified Aldrete Score ≥9 is achieved or until discharge from the recovery area, up to 90 minutes)

• Discharge readiness (Modified Aldrete Score)

  Discharge readiness assessed using the Modified Aldrete Score (range: 0-10; score ≥9 indicates clinical criteria for transfer to ward). Unit of Measure: Units on a scale

  Postprocedural (every 5 minutes in recovery room until Modified Aldrete Score ≥9 is reached, up to 90 minutes post-procedure)

Secondary Outcomes (6)

• Baseline child behavior (Ohio Behavioral Rating Scale)

  Baseline (within 5 minutes prior to study drug administration during the procedure)

• Child's response to drug administration

  Periprocedural (immediately during study drug administration)

• Child's behavior during separation from parent

  Periprocedural (immediately at the time of parent-child separation)

• Use of rescue Sevoflurane due to inadequate sedation

  Intraoperatively, during the suture removal procedure

• Sedation level measured by Modified Ramsay Sedation Scale during procedure

  From drug administration until end of suture removal procedure (expected duration up to 30 minutes)

Other Outcomes (13)

• Heart rate monitoring

  From study drug administration until discharge from recovery room (up to 90 minutes)

• Blood pressure monitoring

  From baseline (pre-sedation) to discharge readiness (within 90 minutes post-procedure)

• Oxygen saturation monitoring

  From study drug administration until discharge from recovery room (up to 90 minutes).

Study Arms (3)

Intramuscular Ketamine

ACTIVE COMPARATOR

Participants assigned to this arm will receive intramuscular ketamine at a dose of 4 mg/kg body weight for analgosedation during suture removal after surgery for congenital clefts. In addition, glycopyrrolate 4 mcg/kg will be administered intramuscularly to reduce salivation. This arm represents the control group, following the established clinical protocol.

Drug: ketamine

Intranasal Nalbuphine

EXPERIMENTAL

Participants assigned to this arm will receive intranasal nalbuphine at a dose of 0.5 mg/kg body weight, administered using a mucosal atomizer device (MAD), for analgosedation during suture removal after cleft surgery. This intervention will be evaluated for its effectiveness, ease of administration, and safety compared with intramuscular ketamine.

Drug: Nalbuphine

Intranasal Dexmedetomidine

EXPERIMENTAL

Participants assigned to this arm will receive intranasal dexmedetomidine at a dose of 3 mcg/kg body weight, administered using a mucosal atomizer device (MAD), for analgosedation during suture removal after cleft surgery. The intervention will be evaluated for sedation depth, response to separation from parents, and overall procedural ease compared with other sedative agents.

Drug: Dexmedetomidine

Interventions

ketamine DRUG

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.

Also known as: Ketamine Hydrochloride, Ketanest, Ketalar

Intramuscular Ketamine

Nalbuphine DRUG

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.

Also known as: Nalbuphine Hydrochloride, Nubain

Intranasal Nalbuphine

Dexmedetomidine DRUG

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.

Also known as: Dexmedetomidine Hydrochloride, Precedex, Dexdor

Intranasal Dexmedetomidine

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6 months to 3 years
• Scheduled for suture removal after surgery for congenital cleft of the palate, alveolar ridge, or lip
• American Society of Anesthesiologists (ASA) physical status I or II
• Written informed consent obtained from parents or legal guardians
• Slovene-speaking family to ensure understanding and compliance
• No contraindications to the use of study medications

You may not qualify if:

• Known allergy or hypersensitivity to ketamine, nalbuphine, or dexmedetomidine
• ASA physical status greater than II
• Significant neurological, psychiatric, or respiratory disorder
• Active or recent upper respiratory tract infection
• Refusal of parental or guardian consent
• Developmental disorder affecting communication or cooperation

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

Department of Maxillofacial and Oral Surgery, University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Cleft Lip

Interventions

Ketamine; Nalbuphine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Tadej P Dovšak, DDS, MD, PhD

  University Medical Centre Ljubljana, Department of Maxillofacial and Oral Surgery

  STUDY CHAIR

Central Study Contacts

Liljana Markova, MD, PhD

CONTACT

00 386 40 802 662; liljana.markova@kclj.si

Eleonora Ivanova, MD

CONTACT

00 386 031 289 803; eleonora.ivanova@kclj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No participants, investigators, or outcome assessors are blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment with three intervention arms. Children aged 6 months to 3 years undergoing suture removal after cleft surgery will be randomly assigned to receive one of the following for procedural sedation: intramuscular ketamine, intranasal nalbuphine, or intranasal dexmedetomidine. The study will compare onset, depth, and duration of sedation, surgeon-rated ease of procedure, recovery time, and safety profiles of each drug.

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: January 14, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 14, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)