Children of Age 2-6years Undergoing Elective Surgery Will be Divided Into Two Groups Randomly. This Study Aims to Evaluate if Intranasal Dexmedetomidine is Better Than Intranasal Ketamine in Producing Sedation and Reducing Parent Separation Anxiety Before Surgery.

NCT07180095 | Not Yet Recruiting Phase 1

• 1 other identifier: aimusa00
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare intranasal dexmedetomidine versus intranasal ketamine as a premedication in children undergoing surgery in our population. Hypothesis is Intranal dexmedetomidine is better than intranasal ketamine in producing preoperative sedation in pediatric patients undergoing surgery under general anesthesia.

Conditions

Sedation; Preoperative Anxiety Experienced by the Pediatric Patient; Anxiolytic Effect; Sedation and Analgesia

Keywords

Preoperative Sedation; Hemodynamic changes; Dexmedetomidine; Dexmedetomidine vs Ketamine

Outcome Measures

Primary Outcomes (1)

• Sedation score as assessed by MOAA/S

  Modified Observer's Assessment of Alertness/ Sedation scale (MOAA/S): 6 = Appears alert and awake, responds readily to name spoken in a normal tone 5 = Appears asleep but responds readily to name spoken in a normal tone 4 = Lethargic response to name spoken in a normal tone 3 = Responds only after the name is called loudly or repeatedly 2 = Responds only after mild prodding or shaking 1 = Does not respond to mild prodding or shaking

  6 months

Secondary Outcomes (2)

• Ease of parental separation using PSAS

  6 months

• Incidence of hypotension and bradycardia in the two groups

  6 months

Study Arms (2)

Intranasal Dexmedetomidine

ACTIVE COMPARATOR

Received Intranasal Dexmedetomidine

Drug: Intranasal dexmedetomidine

Intranasal ketamine

EXPERIMENTAL

Received Intranasal Ketamine.

Drug: Intranasal ketamine

Interventions

Intranasal dexmedetomidine DRUG

intranasal dexmedetomidine 2mcg/kg

Intranasal Dexmedetomidine

Intranasal ketamine DRUG

intranasal ketamine 2mg/kg

Intranasal ketamine

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American society of Anesthesiologist (ASA) class-I and II
• Children 2-6 years of age undergoing elective surgery

You may not qualify if:

• Known hypersensitivity to study drugs
• Refusal of consent
• Known renal, hepatic or cardiac dysfunction
• Nasal deformity or pathology
• Recent upper respiratory infection (within 2 weeks)
• Children undergoing neurosurgery or ophthalmic surgery

Sponsors & Collaborators

• Liaquat National Hospital & Medical College: lead

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09