To compare the effectiveness and safety of two drugs to cause sedation among children for a diagnostic procedure

Comparison of efficacy and safety of intranasal Midazolam with syrup Triclofos for procedural sedation of children undergoing Auditory Brainstem evoked Response audiometry â?? a randomized, double-blinded, placebo controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/10/005115

Enrollment

Registered

2014-10-17

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- Hearing impairment or speech delay among those children from 1 to 6 years of age who are referred for Auditory Brainstem evoked Response audiometry

Interventions

Intervention1: Midazolam nasal spray: 0.5% spray at 0.5 mg/kg (100mcg per spray), the total dose divided and sprayed between two nostrils and half the same dose given at the end of 30 minutes if no se

Eligibility

Inclusion criteria

Inclusion criteria: All children from 1 to 6 years of age, irrespective of developmental maturity who are referred for Auditory Brainstem evoked Response audiometry

Exclusion criteria

Exclusion criteria: 1.Refusal for the procedure 2.Hypersensitivity to Midazolam 3.Nasal allergy 4.Obesity with a body mass index more than or equal to 30 5.ASA grade more than 2

Design outcomes

Primary

Measure	Time frame
1.Safety 2.EfficacyTimepoint: At every 5 minutes interval since onset of sedation to complete recovery	—

Secondary

Measure	Time frame
â?¢Time for parental separation â?¢Nature of parental separation â?¢Time taken for onset of sedation â?¢Duration of procedure â?¢Time taken for recovery â?¢Post recovery behavior â?¢Acceptance by parents â?¢Audiologists satisfaction â?¢Number of attempts Timepoint: At every 15 minutes interval presedation and 5 minutes postsedation	—

Countries

India

Contacts

Public ContactMarie Christy Sharafine S

Christian Medical College, Vellore

jmathew@cmcvellore.ac.in9994516016

Outcome results

None listed

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