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COMPARISON OF TWO MILD SLEEP MEDICINES (DEXMEDETOMIDINE GIVEN UNDER THE TONGUE AND MIDAZOLAM GIVEN AS AN ORAL SYRUP)TO CALM CHILDREN JUST BEFORE SURGERY

Comparison of Atomized Sublingual Dexmedetomidine and Oral Midazolam as Preanaesthetic Medication in Children: A Prospective, Double Blind, Randomised Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010925
Enrollment
60
Registered
2017-12-20
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: null- Any child between the ages of 3 years to 7 years, weighing between 10-20 kilograms, undergoing elective minor surgery.

Interventions

Intervention1: DEXMEDETOMIDINE: Dexmedetomidine is a highly selective alpha 2-adrenergic receptor agonist and possesses sedative, analgesic, perioperative sympatholytic, anaesthetic-sparing, and hemod

Sponsors

Kasturba Hopsital Manipal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anaesthesiologists Physical Status (ASA PS) 1 and 2, Weight 10 to 20 kg, Elective minor surgery under general anesthesia

Exclusion criteria

Exclusion criteria: American Society of Anesthesiologists Physical Status (ASA PS) 3 and 4, Weight 20 kg, Known allergy or hypersensitivity to dexmedetomidine, Parental/ Guardian refusal, Severe developmental delay or behavioural problems, Emergency cases, Cardiac arrhythmia or congenital heart disease, Surgeries more than 4 hour duration, Haemodynamic or respiratory instability, Children at risk for airway obstruction (obstructive sleep apnoea or a craniofacial syndrome), Any treatment with sedatives or anticonvulsants, Children who spit, vomited or refused sublingual administration of medication will also be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Behaviour of the child on separation from parent (Modified Observer assessment of alertness and sedation scale- MOAA/S of 3 or 4)Timepoint: At 2 years

Secondary

MeasureTime frame
- Acceptability of the drug via sublingual route - Mask acceptance (Mask acceptance score of 1 or 2) - Behaviour at time of wake-up from anaesthesia (Wake up behaviour score 1 or2) Timepoint: At 2 years

Countries

India

Contacts

Public ContactPooja Bola Rajendra Devendra Kamath

Kasturba Medical College, Manipal

anitharshenoy@gmail.com9880842121

Outcome results

None listed

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