How Midazolam, Dexmeditomidine & midazolam ketamine combination given by mouth prevents fear, anxiety & to facilitate seperation from parents in children?

COMPARISON OF ORAL MIDAZOLAM ,ORAL DEXMEDETOMIDINE AND ORAL MIDAZOLAM KETAMINE COMBINATION FOR PREMEDICATION IN PAEDIATRIC SURGERY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/01/017081

Enrollment

Registered

2019-01-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q369- Cleft lip, unilateral Health Condition 2: Q899- Congenital malformation, unspecified Health Condition 3: K929- Disease of digestive system, unspecified Health Condition 4: L989- Disorder of the skin and subcutaneous tissue, unspecified Health Condition 5: N51- Disorders of male genital organs in diseases classified elsewhere Health Condition 6: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: Dexmedetomidine: Dexmedetomidine 0.5mcg/kg orally with atropine0.02mg/kg 30minutes before surgery Intervention2: Midazolam and ketamine: Midazolam 0.3mg/kg orally and ketamine 3mg/kg

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA grade 1 and 2 of either sex 2.Age 2 â?? 10 years 3.Scheduled for elective paediatric surgery 4.Patients with written valid and informed consent. 5.duration of surgery 1 to 2 hours

Exclusion criteria

Exclusion criteria: 1.ASA grade 3 and 4 2.Unwilling parents 3.Known allergy to study drug 4.h/o any systemic disease, upper airway disease, CNS dysfunction, gastrointestinal disease 5.Premedication not completely ingested/retained

Design outcomes

Primary

Measure	Time frame
Level of sedation and anxiolysis after premedicationTimepoint: At 0, 10, 20, 30 , 40 minutes after the oral dose of study drugs	—

Secondary

Measure	Time frame
1.Emotional state of child at the time of Separation from parents 2.Mask acceptance 3.Facilitate a smoother and safer induction of anaesthesia 4 Changes in vital parameters like pulse rate, blood pressure and respiratory rate 5.Requirement of general anaesthetic agents 6. Immediate post-operative complications like nausea, vomiting, restlessness, drowsiness, prolonged recovery etc.Timepoint: Baseline at the time of premedication (Zero minute), 10, 20, 30, 40 minutes after the oral dose of study drugs, at the time of induction of anaesthesia, every 15 minutes till 2 hours in postoperative period.	—

Measure

Time frame

1.Emotional state of child at the time of Separation from parents 2.Mask acceptance 3.Facilitate a smoother and safer induction of anaesthesia 4 Changes in vital parameters like pulse rate, blood pressure and respiratory rate 5.Requirement of general anaesthetic agents 6. Immediate post-operative complications like nausea, vomiting, restlessness, drowsiness, prolonged recovery etc.Timepoint: Baseline at the time of premedication (Zero minute), 10, 20, 30, 40 minutes after the oral dose of study drugs, at the time of induction of anaesthesia, every 15 minutes till 2 hours in postoperative period.

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Countries

India

Contacts

Public ContactDr SUCHITA A JOSHI

Govt. Medical College and Hospital, Aurangabad

khadkesuchita@gmail.com9422777903

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026