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Clinical Trials/CTRI/2024/08/072317
CTRI/2024/08/072317Not yet recruitingPhase 3 4

Comparison Of clonidine with midazolam as pre anaesthetic oral medication in paediatric patients in Sawangi, Maharashtra

Jawaharlal Nehru Medical College1 site in 1 country30 target enrollmentStarted: August 31, 2024Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Enrollment
30
Locations
1
Primary Endpoint
To compare oral clonidine with oral midazolam as preanaesthetic medication

Study Overview

Brief Summary

The preoperative period is a stressful period and a major source of anxiety for all patients especially in the paediatric population. Preoperative anxiety in children is a natural response that that produces a negative experience for both patient and parent and thus warrants attention. An ideal pre anaesthetic medication should reduce separation anxiety from the parent, allow for easy and smooth induction of anaesthesia without causing prolongation of emergence or increasing post operative nausea, vomiting and delirium. Oral premedication is commonly used in paediatric population prior to surgery. The ideal pre anaesthetic agent ought to have a fast and dependable onset, negligible results, quick recuperation and ought to work with smooth acceptance of sedation

Midazolam is a water-soluble benzodiazepine. It used as a preanaesthetic medication by several routes including oral, intravenous, intranasal and intramuscular. It has sedative and amnestic effects. Midazolam is the most commonly used oral premedication used in children. Oral midazolam syrup (2 mg/ml) is effective for producing sedation and anxiolysis at a dose of 0.25 mg/kg with minimal effects on ventilation and oxygen saturation even when administered at doses as large

As 1 mg/kg (maximum, 20 mg). Midazolam, 0.5 mg/kg administered orally 30 minutes before induction of anesthesia, provides reliable sedation and anxiolysis in children without producing delayed awakening. Although it is recommended that oral midazolam be administered at least 20 minutes before surgery, there is evidence that significant anterograde amnesia is present when 0.5 mg/kg orally is administered 10 minutes before surgery.

Clonidine is partial α2 receptor agonist. Premedication with clonidine produces preoperative sedation and anxiolysis in children. It also has analgesic properties, decreases volatile anesthetic requirements and improves perioperative hemodynamic stability. Although clonidine is not as common as midazolam as a premedication, it is slowly gaining popularity. It also reduces the requirements for both inhaled anesthetics during surgery as well as opioids in the postoperative period.

Major postoperative issues include pain, emergence delirium, airway obstruction, and hypoventilation. Opioids for pain management can exacerbate airway obstruction and hypoventilation and increase postoperative emesis. Nonsteroidal anti-inflammatory Drugs such as ketorolac are not associated with the respiratory depressant and emetic side effects of opioid administration, but are associated with increased bleeding.Aim

This study aims to Compare the efficacy of oral midazolam as a pre anaesthetic medication to oral clonidine in paediatric patients undergoing tonsillectomy.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant Blinded

Eligibility Criteria

Ages
2.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients aged 2-12 years
  • Patients posted for surgery under general anaesthesia
  • Patients whose parents/ guardians provide consent.

Exclusion Criteria

  • 1.Patients less than 2 year of age 2.Patients more than 12 years of age
  • Weight of more than 95th percentile for age
  • Patients with a difficult airway
  • Patients with central nervous system disorders
  • Patients on anticonvulsants or sedative medications 8.

Outcomes

Primary Outcomes

To compare oral clonidine with oral midazolam as preanaesthetic medication

Time Frame: 1. at separation | 2. at venepuncture | 3. at mask application

Secondary Outcomes

  • Comparison of haemodynamic status of patients recieving oral clonidine & oral midazolam(1. at separation)

Investigators

Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Shyamolima Bhuyan

Jawaharlal Nehru Medical College

Study Sites (1)

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