Comparative study between Intranasal Dexmedetomidine versus Intranasal Midazolam with Oral Promethazine as common premedication in paediatric patients posted for surgery: A Randomized prospective study

AIM

To compare preoperative sedation, ease of parental separation, mask acceptance, and haemodynamic effects of intranasal dexmedetomidine versus intranasal midazolam combined with oral promethazine as premedication in paediatric patients posted for elective surgery.

OBJECTIVES

Primary Objective:

To compare the degree of sedation between the two groups at the time of shifting the patient to the operation room using the Modified Observer Assessment of Alertness or Sedation (MOAA-S) scale.

Secondary Objectives:

1. To assess ease of parental separation when the patient is separated from parents and shifted to the operation room.

2. To assess mask acceptance during anaesthesia induction.

3. To monitor haemodynamic parameters including heart rate, blood pressure, oxygen saturation (SpO2), and respiratory rate (RR) at 0 minute before oral promethazine administration, then every 30 minutes up to intranasal drug administration, and every 10 minutes after intranasal drug administration until induction of anaesthesia (at 0, 30, 60, 90, 100, 110, and 120 minutes).

4. To record any adverse effects associated with either of the study groups.

METHODOLOGY

Ethical Consideration:

The study will follow the principles of the Helsinki Declaration. Approval will be obtained from the Institutional Ethics Committee of GMERS Medical College and Hospital, Gotri, Vadodara. The study will be registered with the Clinical Trial Registry of India. Written informed consent will be obtained from the guardians of all participants. Data confidentiality will be maintained throughout the study.

Study Design:

Prospective randomized comparative study.

Study Setting:

Tertiary care teaching hospital, GMERS Medical College and Hospital, Gotri, Vadodara.

Study Duration:

From October 2025 to March 2026.

Study Population:

All ASA physical status I and II paediatric patients posted for elective surgery under general or regional anaesthesia at GMERS Medical College and Hospital, Gotri, Vadodara.

Sample Size:

A mean sedation score difference of 0.6 with a common standard deviation of 1.1, alpha 0.05, and power 80 percent gives a sample size of 27 per group. Considering attrition, 25 patients per group (total 50 patients) will be included using STATULATOR software.

INCLUSION CRITERIA

1. Children aged 2 to 7 years.

2. Weight between 5 and 20 kilograms.

3. ASA physical status I or II.

4. Scheduled for elective surgery (general surgery, ENT, or orthopaedic).

5. Duration of surgery between 1.5 and 2 hours.

EXCLUSION CRITERIA

1. Parental refusal to participate.

2. Known allergy to study drugs.

3. Nasal pathology or upper respiratory tract infection.

4. Higher grade adenotonsillar hypertrophy (Grade 3 or 4).

RANDOMIZATION

Patients will be randomly allocated into two groups.

Group DP: Intranasal dexmedetomidine 2 microgram per kilogram plus oral promethazine 1 milligram per kilogram.

Group MP: Intranasal midazolam 0.3 milligram per kilogram plus oral promethazine 1 milligram per kilogram.

DRUG ADMINISTRATION

Oral promethazine syrup will be administered 120 minutes before induction. The intranasal drug will be given 30 minutes prior to induction.

The child will be positioned supine on the parent’s lap with gentle head tilt of 15 degrees. The required dose will be prepared as per body weight and filled in a 1 ml insulin syringe. Half the volume will be administered into each nostril using a nasal dropper. The position will be maintained for 60 to 90 seconds before allowing the child to rest comfortably.

STUDY PROCEDURE

Pre-anaesthetic evaluation will include history, general and systemic examination, airway assessment, and necessary investigations.

Fasting guidelines will be followed (solid food for 6 hours, clear liquids for 2 hours).

IV cannula will be inserted after application of EMLA cream once the child is mildly sedated after oral promethazine.

Sedation score and haemodynamic parameters will be recorded at 0 minute before oral promethazine, every 30 minutes up to intranasal drug administration, and every 10 minutes thereafter until shifting to the operation room (at 0, 30, 60, 90, 100, 110, and 120 minutes).

Child-parent separation anxiety will be scored. If unsatisfactory (score 3), intravenous ketamine 0.5 mg per kg will be given to facilitate separation.

In the operation room, mask acceptance score will be assessed. ASA standard monitors (ECG, NIBP, SpO2, capnography) will be attached.

Other premedications such as glycopyrrolate 0.004 mg per kg, ondansetron 0.08 mg per kg, and paracetamol 15 mg per kg intravenously will be administered.

Further anaesthetic management will be as per the attending anaesthesiologist.

MONITORING AND ASSESSMENT

Sedation will be assessed using the MOAA-S scale at each time interval (0, 30, 60, 90, 100, 110, and 120 minutes).

Vital signs (heart rate, blood pressure, oxygen saturation, and respiratory rate) will be recorded simultaneously.

Ease of parental separation will be evaluated using a 3-point separation score.

Mask acceptance will be assessed using a 4-point mask acceptance scale.

OUTCOME MEASURES

Primary Outcome: Difference in sedation level between Group DP and Group MP.

Secondary Outcomes:

1. Ease of parental separation during transfer to the operation theatre.

2. Mask acceptance score during anaesthesia induction.

3. Hemodynamic parameters (heart rate, blood pressure, SpO2, and RR).

4. Postoperative monitoring for adverse events including bradycardia, hypotension, respiratory depression, agitation, nausea, or vomiting.