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comparing two sedation medicines for breathing ,heartrate and recovery of children aged 4-9 years undergoing dental treatment

Comparative Evaluation of Intraoperative and Postoperative Respiratory and Hemodynamic events using Dexmedetomidine-Propofol and Fentanyl -Propofol in 4-9 years Children in Outpatient Dental Sedation: A Double blinded Randomised Cross-over Study. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110955
Enrollment
47
Registered
2026-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: Dexmedetomidine-Propofol Sedation: Children will receive IV Dexmedetomidine in combination with Propofol for Outpatient Dental sedation procedure.Respiratory and Hemodynamic parameters

Sponsors

MGM DENTAL COLLEGE AND HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants aged between 4-9 years of age will be included Participants with ASA 1 will be included Frankl behaviour rating scale 1 and 2 will be included Participants indicated for Pulp therapy Participants who will give informed written consent to participate in study.

Exclusion criteria

Exclusion criteria: Physically, intellectually and medically compromised participants. An upper respiratory tract infection with nasal discharge or respiratory distress Participants with history of known allergy to sedative drugs and dental materials

Design outcomes

Primary

MeasureTime frame
There will be significant difference in Intraoperative and Postoperative Respiratory and Hemodynamic events between dexmedetomidine-propofol and fentanyl-propofol in children aged 4-9 years in outpatient dental sedation.Timepoint: intraoperative and postoperative every baseline 15mins,30 mins

Secondary

MeasureTime frame
pain and postoperative nausea and vomitingTimepoint: postoperatively;additional bolus of propofolTimepoint: intraoperatively

Countries

India

Contacts

Public ContactAKANKSHA APANKAR

MGM DENTAL COLLEGE AND HOSPITAL KAMOTHE,NAVI MUMBAI

s_shrirang@yahoo.com8879173927

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026