Evaluation of efficacy of oral midazolam syrup when given before surgery in paediatric age group

â??A CLINICAL EVALUATION OF MIDAZOLAM SYRUP PREMEDICATION IN PAEDIATRIC PATIENTS .A RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDYâ??

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/10/006234

Enrollment

100

Registered

2015-10-05

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- Patients of age group between 1to 6 year requiring sedation who are undergoing surgery

Interventions

Intervention1: ORAL MIDAZOLAM SYRUP: 0.25mg/kg Oral midazolam syrup containg 2mg midazolam in 1 ml. is given.total volume of drug is made 5 ml by adding distilled water given 45 minutes prior to surg

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status 1 &2 Age between 1 to 6 yr

Exclusion criteria

Exclusion criteria: 1} with unstable hemodynamic and respiratory function. 2} Mentally retarded patients. 3} On treatment with sedatives and anticonvulsants. 4} Parental refusal. 5} With any gastrointestinal disorders e.g. nausea,vomiting,diarrhoea

Design outcomes

Primary

Measure	Time frame
PATIENT BECOME CALM, SEDATED, ANXIETY FREE ,EASY ACCESS OF IV LINE IN CHILDREN, SEPARATION FROM PARENTS WITHOUT DISTRESSTimepoint: 0 min. 5, 10, 15, 20, 25, 30, 35, 40, 45min.	—

Secondary

Measure	Time frame
ComplicationsTimepoint: 0 min. 5, 10, 15, 20, 25, 30, 35, 40, 45min.	—

Countries

India

Contacts

Public ContactPATEL JALDEEP BABUBHAI

GOVT. MEDICAL COLLEGE, BHAVNAGAR

drshilpadoshi@yahoo.in9428810763

Outcome results

None listed

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