Comparative study of ketamine with dexmedetomidine versus ketamine with midazolam as for allay anxiety before surgery both given in intranasal route in paediatric children undergoing below umbilical surgery

‘Comparative Study Of Intranasal Ketamine With Dexmedetomidine Versus Intranasal Ketamine With Midazolam As Premedication For Sedation In Paediatric Infraumbilical Surgeries ‘A Randomized Double Blind Study. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/058127

Enrollment

Registered

2023-09-29

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Intranasal Ketamine and intranasal Midazolam.: In other groups we will give intranasal ketamine 1mg/kg with midazolam 0.2mg/kg 30min prior the surgery.here we will monitor sedation s

Eligibility

Inclusion criteria

Inclusion criteria: In this study we include from3-8 years .As these groups of children are more prone for separation anxiety .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
we will compare sedation in both groups preoperatively in terms of sedation score using MOASS scale just prior drugs administration, and after 10 minutes 20 minutes and 30 minutes following administration of drugs. Timepoint: Sedation score will be assessed prior drugs administration and after 10 minutes ,20 minutes and 30 minutes following administration of drugs.	—

Secondary

Measure	Time frame
• we will compare parental separation in children in both the groups in terms of Parental separation score. •we will compare in both groups Parent satisfaction score. We will compare Mask acceptance in terms of mask acceptance score during induction in both the groups. We will assess Preoperative, intraoperative & postoperative vital parameters in both groups. •Incidence of adverse events related to drugs in both the groups. We will compare in both groups Postoperative emergence (Cravero score). Also we will asses sedation in children post operatively in terms of sedation score Timepoint: Parental separationAt the time of wheeling in OT. Mask acceptance score-at the time of induction. Vitals -preoperative vitals prior to drug administration, after 10 ,20 & 30 minutes. Intraoperative vitals at the time of induction, after 10 ,20,30,60,90 & 120 minutes. Postoperative vitals at 0min,after 15,30,60,120 minutes. Postoperative emergence score immediately after extubation. Postoperative sedation score immediately after shifting the patient to PACU,after 15 ,30,60,120 minutes .	—

Measure

Time frame

• we will compare parental separation in children in both the groups in terms of Parental separation score. •we will compare in both groups Parent satisfaction score. We will compare Mask acceptance in terms of mask acceptance score during induction in both the groups. We will assess Preoperative, intraoperative & postoperative vital parameters in both groups. •Incidence of adverse events related to drugs in both the groups. We will compare in both groups Postoperative emergence (Cravero score). Also we will asses sedation in children post operatively in terms of sedation score Timepoint: Parental separationAt the time of wheeling in OT. Mask acceptance score-at the time of induction. Vitals -preoperative vitals prior to drug administration, after 10 ,20 & 30 minutes. Intraoperative vitals at the time of induction, after 10 ,20,30,60,90 & 120 minutes. Postoperative vitals at 0min,after 15,30,60,120 minutes. Postoperative emergence score immediately after extubation. Postoperative sedation score immediately after shifting the patient to PACU,after 15 ,30,60,120 minutes .

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Countries

India

Contacts

Public ContactDr.Namrata Sharma

Chacha Nehru Bal Chikitsalaya

kmlgeeta@rediffmail.com9643308229

Outcome results

None listed

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