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Assessing effectiveness and safety of two medications :nasal ketamine and oral promethazine as premedication in pediatric patients undergoing routine operations

PREMEDICATION EFFICACY COMPARISON IN CHILDREN: INTRANASAL KETAMINE V/S ORAL PROMETHAZINE -A RANDOMIZED DOUBLE BLIND PROSPECTIVE STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/03/006704
Enrollment
60
Registered
2016-03-03
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- 60 patients of ASA I of age group 2-8 years scheduled for elective general surgeries, urosurgeries, plastic surgeries and ENT were randomly selected and taken in to study.

Interventions

Intervention1: Group B: intranasal ketamine: intranasal ketamine 5mg/kg as premedication 20 min before elective surgery. Control Intervention1: Group A: oral promethazine: oral promethazine 1mg/kg as

Sponsors

St Stephens Hospital Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 60 children of ASA I physical status of age group 2-8 years scheduled for elective general surgeries, urosurgeries, plastic surgeries and ENT were randomly selected and taken in to study.

Exclusion criteria

Exclusion criteria: children of age less than 2 yrs or more than 8 years of age; children with upper respiratory tract infection; with syndromic features or menifestations; with any cardiac or respiratory anomalies

Design outcomes

Primary

MeasureTime frame
Premedication profile as sedation or calmness prior to inductiuon of anaesthesia or surgery.Timepoint: Group A: two hours before elective surgery. Group B: 20 min before elective surgery.

Secondary

MeasureTime frame
Haemodynamic stability in perioperative periodTimepoint: after premedication up to start of induction;side effect profile related to given drugTimepoint: after premedication up to completion of surgery

Countries

India

Contacts

Public ContactGrace Cherian

St. Stephens Hospital, New Delhi

cherian.grace@rediffmail.com9971176033

Outcome results

None listed

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