Intranasal midazolam/ketamine combination for preoperative sedation in pediatrics

Intranasal midazolam alone versus midazolam/ketamine combination for preoperative sedation in pediatric patients undergoing ophthalmic procedures: A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201220049777N1

Enrollment

Registered

2020-12-31

Start date

2021-01-15

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

Preoperative sedation in pediatric patients undergoing ophthalmic procedures..

Interventions

Intervention 1: Intervention group 1: The patients will be given midazolam intranasally in a dose of 0.5 mg/kg. The drug will be administered 15 minutes prior to induction of anesthesia. Intervention

Eligibility

Sex/Gender

All

Age

3 Years to 7 Years

Inclusion criteria

Inclusion criteria: Children (male or female) aged from 3 to 7 years old ASA I or II Children with disability or special needs such as autism and Down syndrome Children who underwent multiple operative procedures Children with history of stormy anesthetic induction or emergence

Exclusion criteria

Exclusion criteria: Anticipated difficult airways, such as facial deformity, cervical spine injury, or some syndromes (e.g. Pierre robin syndrome, Apert syndrome, and Teacher Collins syndrome). Increased risk of aspiration as in anatomical abnormalities, such as cleft palate and problems in the esophagus, neuromuscular diseases, and cerebral palsy. Central or obstructive sleep apnea. Previous allergy or adverse reaction to the used drugs.

Design outcomes

Primary

Measure	Time frame
Postoperative agitation. Timepoint: at the time of patient recovery. Method of measurement: Emergence Agitation Scale.;Easiness of separation. Timepoint: at the time of separation. Method of measurement: Separation and Induction Score.;Preoperative level of sedation. Timepoint: 10 minutes after sedation is given. Method of measurement: 6-Point Pediatric Sedation State Scale.	—

Secondary

Measure	Time frame
Oxygen saturation. Timepoint: every 5 minutes intraoperatively. Method of measurement: pulse oximetry.;Pulse rate. Timepoint: every 5 minutes intraoperatively. Method of measurement: manually.;Postoperative nausea and vomiting. Timepoint: 30 minutes after recovery. Method of measurement: clinical evaluation.	—

Countries

Egypt

Contacts

Public ContactNoha Osama

Research Institute of Ophthalmology

noha.a.osama22@gmail.com+20 2 35718304

Outcome results

None listed

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