Comparing the effectiveness of Ketamine-Dexmedetomidine vs. ketamine-midazolam combination for providing sedation and analgesia in children undergoing infraumbilical surgeries under caudal anesthesia.

Ketamine-Dexmedetomidine Vs Ketamine-Midazolam combination for peri-operative Sedo-analgesia in preschool children undergoing infraumbilical surgeries under caudal anaesthesia - A comparative randomized study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063544

Enrollment

Registered

2024-03-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: Q531- Undescended testicle, unilateral Health Condition 2: K409- Unilateral inguinal hernia, without obstruction or gangrene Health Condition 3: K37- Unspecified appendicitis

Interventions

Intervention1: Caudal Anaesthesia under sedo-Analgesia: Under all aseptic precautions a sterile blunt 22-gauge needle was introduced in the caudal space by identifying sacral hiatus in between two sac

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA Grade I to III 2. Infraumbilical elective surgeries

Exclusion criteria

Exclusion criteria: 1. Patient’s parents or caretaker’s refusal. 2. Allergy to the drugs used in the study. 3. Pre-existing neuromuscular disorder or spinal deformities. 4. Raised ICT (Intra Cranial Tension). 5. Coagulation defect. 6. Local site infection. 7. Severe hypovolemia

Design outcomes

Primary

Measure	Time frame
To Compare the Perioperative Sedo-Analgesic Efficacy of Intravenous Ketamine-Dexmedetomidine and Ketamine-Midazolam Combination in Paediatric Patients Posted for Infraumbilical Surgeries Under Caudal Epidural Block to- 1. observe limb movement at time of needle prick for caudal block. 2. observe onset time and level of sedation. 3. observe intraoperative hemodynamic parameters. Timepoint: till end of the surgery.	—

Measure

Time frame

To Compare the Perioperative Sedo-Analgesic Efficacy of Intravenous Ketamine-Dexmedetomidine and Ketamine-Midazolam Combination in Paediatric Patients Posted for Infraumbilical Surgeries Under Caudal Epidural Block to- 1. observe limb movement at time of needle prick for caudal block. 2. observe onset time and level of sedation. 3. observe intraoperative hemodynamic parameters. Timepoint: till end of the surgery.

—

Secondary

Measure	Time frame
1) To observe quality and duration of postoperative sedation. 2) Surgeon satisfaction. 3) To observe any complications and side effects. Timepoint: till the drug effect is over.	—

Countries

India

Contacts

Public ContactKanta Bhati

Sardar Patel Medical College Bikaner

drkantabhati67@gmail.com09413466688

Outcome results

None listed

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