A randomised clinical trial to study the effects of four combinations of drugs for Procedural Sedation and Analgesia in uncooperative Paediatric dental patients.

â??A RANDOMISED CLINICAL TRIAL ON COMPARATIVE EVALUATION OF INTRANASAL COMBINATIONS OF MIDAZOLAM-KETAMINE, DEXMEDETOMIDINE-KETAMINE, MIDAZOLAM-FENTANYL AND DEXMEDETOMIDINE-FENTANYL FOR PROCEDURAL SEDATION AND ANALGESIA IN PAEDIATRIC DENTAL PATIENTSâ??

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/12/038799

Enrollment

124

Registered

2021-12-21

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: 1)GROUP DK - Intranasal combination of Dexmedetomidine and Ketamine, 2)GROUP MF - Intranasal combination of Midazolam and Fentanyl, 3)GROUP DF - Intranasal combination of Dexmedetomidin

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients requiring any invasive dental treatment. 2)Patients who are rated as positive and negative on Frankelâ??s behaviour rating scale. 3)Patients of physical status American Society of Anesthesiologists (ASA) class I and II. 4)Signed informed consent by the parents/guardians.

Exclusion criteria

Exclusion criteria: 1)Patients of physical status American Society of Anesthesiologists (ASA) Class III and IV. 2)Patients who have a history of any systemic diseases, like cardiorespiratory dysfunction and CNS dysfunction. 3)Patients who are allergic to any of the drugs considered for the present study or history of any adverse reactions to anesthetic/ sedative agents. 4)Patients with any intranasal pathology, nasal obstruction (obstructive sleep apnea) or with any congenital anomaly.

Design outcomes

Primary

Measure	Time frame
1)Evaluation of the onset of sedation, monitoring of haemodynamic parameters and duration of action of different combinations of drugs used for procedural sedation and analgesia. 2)Evaluation of the depth of sedation in patients during treatment under procedural sedation and analgesia.Timepoint: 1)Evaluation of the onset of sedation and monitoring of haemodynamic parameters at every 10 mins of procedure and duration of action of different combinations of drugs used for procedural sedation and analgesia. 2)Evaluation of the depth of sedation in patients at baseline, at 30 minutes after start of treatment and at the end of treatment under procedural sedation and analgesia.	—

Measure

Time frame

1)Evaluation of the onset of sedation, monitoring of haemodynamic parameters and duration of action of different combinations of drugs used for procedural sedation and analgesia. 2)Evaluation of the depth of sedation in patients during treatment under procedural sedation and analgesia.Timepoint: 1)Evaluation of the onset of sedation and monitoring of haemodynamic parameters at every 10 mins of procedure and duration of action of different combinations of drugs used for procedural sedation and analgesia. 2)Evaluation of the depth of sedation in patients at baseline, at 30 minutes after start of treatment and at the end of treatment under procedural sedation and analgesia.

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Secondary

Measure	Time frame
1)Evaluation of hemodynamic parameters (like blood pressure, heart rate and oxygen saturation) of patients before, during and after undergoing dental treatment under procedural sedation and analgesia. 2)Behaviour changes in patients during treatment under procedural sedation and analgesia. 3)Observing relief in pain of patients during invasive dental procedure under procedure sedation and analgesia. 4)Comparing the ease of treatment completion under procedural sedation and analgesia.Timepoint: During the time of treatment.	—

Measure

Time frame

1)Evaluation of hemodynamic parameters (like blood pressure, heart rate and oxygen saturation) of patients before, during and after undergoing dental treatment under procedural sedation and analgesia. 2)Behaviour changes in patients during treatment under procedural sedation and analgesia. 3)Observing relief in pain of patients during invasive dental procedure under procedure sedation and analgesia. 4)Comparing the ease of treatment completion under procedural sedation and analgesia.Timepoint: During the time of treatment.

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Countries

India

Contacts

Public ContactProf Dr Rakesh Kumar Chak

Faculty of Dental Sciences, King George Medical University

dr.chakrakeshkr@yahoo.com9453904150

Outcome results

None listed

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