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.

NCT ID: NCT07180095

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-07-30

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.

Detailed Description

This is a prospective, randomized, double-blind, controlled trial with Minimum 6 months of data collection. Patients will be randomly divided into 2 groups; Group D and Group K with 30 patients in each group. Group D will receive dexmedetomidine 2 mcg/kg intranasal, diluted in normal saline to a total volume of 1 mL and will be administered 0.5 mL per nostril while group K will receive ketamine 2mg/kg intranasal, diluted in normal saline to a total volume of 1 mL similarly divided into two nostrils. The study drugs will be prepared by a second anesthesiologist who will not be involved in subsequent assessments. The calculated dose for each patient will be administered 30 minutes before induction of anesthesia in preoperative holding area in parental/guardian presence. Sedation level will be assessed at 10 minutes interval for the next 30 minutes or until the child will be shifted to the operating room using MOAA/S and ease of parental separation will be scored using PSAS. All patients will be monitored using standard ASA monitoring (ECG, non-invasive blood pressure , pulse oximetry) before induction then every 5 minutes till the end of surgery or a maximum of 1 hour in the operating room. All patients will be induced with 6-8% sevoflurane in 100% oxygen and a 24-G IV access will be secured once the child is asleep. Nalbuphine 0.1 mg/kg IV, atracurium 0.5mg/kg IV (or rocuronium 0.6mg/kg if there's contraindication to atracurium). After endotracheal intubation or laryngeal mask airway (LMA) insertion, all patients will be maintained with 50% O2 in air with isoflurane. Ventilation will be adjusted to maintain an end tidal CO2 concentration between 30-40mmHg. All patients will be given IV paracetamol 20mg/kg as part of multimodal analgesia. If heart rate drops <70 bpm, atropine 10mcg/kg I/V will be used and hypotension will be treated with IV adrenaline 10mcg/kg. Neuromuscular blockade will be reversed with 50mcg/kg neostigmine and 10mcg/kg glycopyrolate. After regaining regular and spontaneous breathing, the endotracheal tube or LMA will be removed and the child will be shifted to post-anesthesia care unit (PACU).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Intranasal Dexmedetomidine

Received Intranasal Dexmedetomidine

Group Type: ACTIVE_COMPARATOR

Intranasal dexmedetomidine

Intervention Type: DRUG

intranasal dexmedetomidine 2mcg/kg

Intranasal ketamine

Received Intranasal Ketamine.

Group Type: EXPERIMENTAL

Intranasal ketamine

Intervention Type: DRUG

intranasal ketamine 2mg/kg

Interventions

Intranasal dexmedetomidine

intranasal dexmedetomidine 2mcg/kg

Intervention Type: DRUG

Intranasal ketamine

intranasal ketamine 2mg/kg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liaquat National Hospital & Medical College

OTHER

Sponsor Role: lead

Responsible Party

Aimon Irshad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

aimusa00

Identifier Type: -

Identifier Source: org_study_id