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A clinical trial to study the effects of two drugs, oral midazolam and intranasal dexmedetomidine as premedication in children.

A double blind randomized comparative study of intranasal dexmedetomidine versus oral midazolam as premedication in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/10/004066
Enrollment
60
Registered
2013-10-15
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- Sedative and anxiolytic effect of oral midazolam syrup and nasal dexmedetomedine on children undergoing minor surgeries will be studied.

Interventions

Intervention1: midazolam: Child will receive 0.01ml/kg normal saline intranasally 45 min before expected time of surgery and syp. Midazolam 0.5mg/kg orally [Syrup containing midazolam 2mg/ml will be

Sponsors

Lokamanya Tilak Muncipal Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA - I & II 2.Minor surgical procedures like Herniotomy, Orchidopexy, Hypospadiasis repair, Split skin grafting, Excision of lumps, Circumcision, Cystoscopy, Excision of lymph nodes etc. 3.Parent consenting for the study

Exclusion criteria

Exclusion criteria: 1.Age 12 years 2.ASA III and above 3.Hypersensitivity to midazolam or dexmedetomidine 4.Patients with airway problems 5.Patients with respiratory disorders 6.Patients with cardiovascular disorders 7.Patients with central nervous system disorders 8.Patients with liver, renal and gastrointestinal disorders

Design outcomes

Primary

MeasureTime frame
1.Preoperative sedation 2.Ease of separation from parents 3.Quality of mask acceptance 4.Hemodynamic status 5.Ease of induction 6.Post operative sedation 7.Post operative analgesia 8.Incidence of post operative nausea, vomiting, agitation and shivering.Timepoint: Preop every 10 min after giving premedication Intraop at the time of induction & every 5 minutes for first 30 minutes & thence every 10 minutes till the end of surgery: Post- operatively every 15 minutes for 1st hour & every 30 minutes for another 2 hours.

Secondary

MeasureTime frame
NOT APPLICABLETimepoint: NOT APPLICABLE

Countries

India

Contacts

Public ContactPrakash Bharamagoudar

LTMMC AND LTMGH

dradmalde@yahoo.com02224073257

Outcome results

None listed

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