A comparison of effectiveness of Oral Dexmedetomidine,ketamine alone versus combination of both in sedation and anxiety, in children posted for surgery

A Comparative study of oral Dexmedetomidine,Ketamine alone Versus a combination of both as premedication in paediatric patients posted for surgery - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066183

Enrollment

Registered

2024-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: Q35-Q37- Cleft lip and cleft palate Health Condition 2: N40-N53- Diseases of male genital organs Health Condition 3: H60-H95- Diseases of the ear and mastoid process Health Condition 4: H00-H59- Diseases of the eye and adnexa Health Condition 5: V00-Y99- External causes of morbidity

Interventions

Intervention1: Oral Premedication with Ketamine ,Dexmedetomidine and combination of both drugs: The patients will be grouped into 3 groups according to the drugs they are given 1. Group D - Dexmedeto

Eligibility

Inclusion criteria

Inclusion criteria: patients with ASA 1 or 2 patients posted for elective surgery

Exclusion criteria

Exclusion criteria: Patients below age 2 and above age 12 patient belonging to ASA grade more than 2 Patient undergoing any emergency surgry syndromic children Child with Respiratory Tract Infections

Design outcomes

Primary

Measure	Time frame
Compare the effects of Dexmedetomidine, Ketamine and combination of both in sedation, analgesia and reducing anxietyTimepoint: The level of sedation of the patient will be examined before and after 5,10,20,30,40,60 minutes of giving premedicvation on a five point scale (SS-5) 1.Rarely awake,responds to shouting or shaking 2.Asleep eyes closed 3.Sleepy but eyes open spontaneously 4.Awake 5.Agitated	—

Measure

Time frame

Compare the effects of Dexmedetomidine, Ketamine and combination of both in sedation, analgesia and reducing anxietyTimepoint: The level of sedation of the patient will be examined before and after 5,10,20,30,40,60 minutes of giving premedicvation on a five point scale (SS-5) 1.Rarely awake,responds to shouting or shaking 2.Asleep eyes closed 3.Sleepy but eyes open spontaneously 4.Awake 5.Agitated

—

Secondary

Measure	Time frame
study will compare oral Dexmedetomedine, oral ketamine and combination of both in their effects on the ease of separation from parents, the acceptance for IV cannulation and face mask applicationTimepoint: After assessing the level of sedation, i.e., 40 minutes from giving the pre-medication, the difficulty in separating the patients from their parents will be evaluated on a 4 point scale After moving the patient to the operating room, the IV acceptability score will be assesed on a 4 point scale After inserting the IV cannulation, the mask acceptance by the patients will be evaluated on a 5 point scale	—

Measure

Time frame

study will compare oral Dexmedetomedine, oral ketamine and combination of both in their effects on the ease of separation from parents, the acceptance for IV cannulation and face mask applicationTimepoint: After assessing the level of sedation, i.e., 40 minutes from giving the pre-medication, the difficulty in separating the patients from their parents will be evaluated on a 4 point scale After moving the patient to the operating room, the IV acceptability score will be assesed on a 4 point scale After inserting the IV cannulation, the mask acceptance by the patients will be evaluated on a 5 point scale

—

Countries

India

Contacts

Public ContactDr Jigisha Badheka

Pandit Deendayal Upadhyay Medical College, Rajkot

jagu_jigi@yahoo.com9879570170

Outcome results

None listed

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