A clinical trial to compare the effects of drug dexmedetomidine when given via nasal route and intravenous route in patients of age group 1 month to 12 years for removal of foreign body in oesophagus.

A randomized study to compare efficacy between intranasal and intravenous dexmedetomidine for removal of foreign body in oesophagus at cricopharynx level in Pediatric patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058515

Enrollment

Registered

2023-10-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: T181- Foreign body in esophagus Health Condition 2: 3- Administration

Interventions

Intervention1: Intranasal Dexmedetomidine: Intranasal 3 microgram per kg of body weight approximately 40 minutes before taking patient into operation theater and wait for sedation score 3 or more for

Eligibility

Inclusion criteria

Inclusion criteria: ASA Physical status classification 1 and 2. Pediatric patients between the age of 1 month to 12 years with foreign body in oesophagus at cricopharynx level.

Exclusion criteria

Exclusion criteria: Patients having ASA physical status classification of 3 and 4. Patients party refusal. Patients having known allergy or hypersensitivity reaction to dexmedetomidine. Patients with organ dysfunction, mental retardation, cardiac arrhythmia. Patients having any congenital structural anomaly or disorders. Patients having severe preoperative respiratory impairment. Patients having family history of previous malignant hyperthermia.

Design outcomes

Primary

Measure	Time frame
1.To compare the onset of sedation and sedation level between intranasal and intravenous route for dexmedetomidine preoperatively. 2. To compare perioperative pain between intranasal and intravenous route for dexmedetomidine administration.Timepoint: 1.To compare the onset of sedation and sedation level between intranasal and intravenous route for dexmedetomidine preoperatively at baseline,10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 50 minutes, 60 minutes and at 2 hour. 2. To compare perioperative pain between intranasal and intravenous route for dexmedetomidine administration at baseline, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes and at 2 hour.	—

Measure

Time frame

1.To compare the onset of sedation and sedation level between intranasal and intravenous route for dexmedetomidine preoperatively. 2. To compare perioperative pain between intranasal and intravenous route for dexmedetomidine administration.Timepoint: 1.To compare the onset of sedation and sedation level between intranasal and intravenous route for dexmedetomidine preoperatively at baseline,10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 50 minutes, 60 minutes and at 2 hour. 2. To compare perioperative pain between intranasal and intravenous route for dexmedetomidine administration at baseline, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes and at 2 hour.

—

Secondary

Measure	Time frame
To compare the hemodynamic variables- Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, oxygen saturation between intranasal and intravenous route for dexmedetomidine administration.Timepoint: up to 5 hours;The separation score while separating the patient from their parents before taking into operation theatre.Timepoint: up to 1 hour;To compare the duration of procedure in both groups.Timepoint: till the end of procedure;To compare side effects/ complications any event of body movement, bronchospasm/ laryngospasm,coughing in post anaesthesia care unit, if any.Timepoint: up to 1 hour	—

Measure

Time frame

To compare the hemodynamic variables- Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, oxygen saturation between intranasal and intravenous route for dexmedetomidine administration.Timepoint: up to 5 hours;The separation score while separating the patient from their parents before taking into operation theatre.Timepoint: up to 1 hour;To compare the duration of procedure in both groups.Timepoint: till the end of procedure;To compare side effects/ complications any event of body movement, bronchospasm/ laryngospasm,coughing in post anaesthesia care unit, if any.Timepoint: up to 1 hour

—

Countries

India

Contacts

Public ContactDr Rahul Gupta

Uttar Pradesh University of Medical Sciences, Saifai, Etawah

lucknow.manoj@gmail.com9410854970

Outcome results

None listed

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