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A clinical trial to find out whether nasal administration of Ketamine is as good as intravenous route for sedation prior to minor procedures in children presenting to the Emergency department.

A Prospective, randomized controlled, single-blinded trial comparing the efficacy of intranasal and intravenous administration of Ketamine for procedural sedation in paediatric patients in the Emergency Department

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/08/004919
Enrollment
40
Registered
2014-08-25
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- Procedural sedation and analgesia

Interventions

Intervention1: Ketamine: 5 mg/kg
intranasal
only once Control Intervention1: Ketamine: 1 mg/kg
intravenous
mostly once but if top-up was needed another dose was given

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age : 1 to 15 years 2. Any procedure requiring sedation for 20 minutes or less eg. Splinting, fracture reduction, wound debridement etc 3. At least 4 hours after last meal

Exclusion criteria

Exclusion criteria: 1. Local problems at the drug administration site 2. Patients in whom pain assessment is difficult 3. Altered mentation (Glasgow Coma Scale 15/15)

Design outcomes

Primary

MeasureTime frame
SedationTimepoint: monitored by standard scoring systems at 0,15,30,60,240 minutes—

Secondary

MeasureTime frame
Recovery period, adverse effectsTimepoint: 0,15,30,60,240—

Countries

India

Contacts

Public ContactDr Rachel Gnanaprakasam

Christian Medical College Hospital

rachelgnanaprakasam@gmail.com04162282225

Outcome results

None listed

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