Comparison of Dexmedetomidine and Midazolam as Intanasal Premedication in Children

Phase 4

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2018/03/012807
• Lead Sponsor: Principle Investigator

Brief Summary

**SUMMARY**

This study was conducted in thedepartment of anesthesiology and critical care at the pediatric surgeryoperating theatre complex, St. John’s Medical College Hospital, Bangalore.

In this study, 104 ASA grade I andII children between 2-10 years, who were scheduled for elective surgicalprocedures were observed. The patients that received intranasal Dexmedatomidine(1µg/kg) were allotted to group D and the patients that received intranasalMidazolam (0.2mg/kg) were put under group M.

30 minutes after premedication withthe intranasal drug, the Parental Separation Anxiety Score was assessed on a 4point scale and sedation of the child was assessed using a 6 point ModifiedObserver’s Assessment of Alertness/Sedation Scale. Prior to anesthesiainduction the Mask Acceptance Score was assessed using a 5 point scale.

There was a marked variation betweenthe two groups with regards to the parental separation. There was astatistically significant data which concluded the children premedicated withintranasal Dexmedetomidine separated much more easily than those premedicatedwith intranasal Midazolam.

The Modified Observer’s Assessmentof Alertness/Sedation scores showed a significantly better score in theDexmedetomidine group compared to Midazolam, indicating a better degree ofsedation among those premedicated with Dexmedetomidine.

There was a statisticallysignificant difference with respect to mask acceptance before induction ofanesthesia. The patients premedicated with intranasal Dexmedetomidine had bettermask acceptance compared to those premedicated with intranasal Midazolam.

The demographic data recorded foundno difference in the age or gender between the two groups.

After premedication the childrenwere monitored for 30 minutes at every 10 minute interval, prior to inductionof anesthesia. Vital signs (heart rate, BP, respiratory rate and oxygensaturation) were recorded. After administering intranasal premedication it wasfound the there was a fall in heart rate, without significant fall in bloodpressure in the patients who were administered Dexmedetomidine. There was nochange in the respiratory rate or oxygen saturation.

Intra-operatively, the vitals weremonitored every 5 minute interval for 30 minutes and thereafter every 10minutes till the end of the procedure. The intra-operative period showed nosignificant variation in the vital parameters between the two groups.

Postoperatively the children were monitored for 24 hours after the procedure. Thevitals were stable and there were no adverse reactions in any of the children.

Therefore, based on these resultsit can be concluded that intranasal Dexmedetomidine (1 µg/kg) is moreefficacious than intranasal Midazolam (0.2 mg/kg) for premedicatingchildren undergoing short elective surgical procedures.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study Completion: 2017-01-12
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Children aged 2-10 years undergoing minor surgical procedures under general anaesthesia American Society of Anaestheiologists (ASA) Physical Status I & II grade of patients.

Exclusion Criteria

• Parent refusal Known allergy to the drugs under study.
• Cardiac dysrhythmias and/or congenital heart disease Psychotropic medication use Mental retardation Nasal disorders interfering with administration of medication as recurrent nasal bleeding or nasal masses.
• Children who spat or refused intranasal administration of medication.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified observer’s Assessment of Alertness/Sedation scale (MOAA/S).	Modified observer’s Assessment of Alertness/Sedation scale (MOAA/S). 30 minutes. | Parental Separation Anxiety scale (PSAS). 30 minutes. | Mask Acceptance Score(MAS). 30 minutes.
Mask Acceptance Score(MAS).	Modified observer’s Assessment of Alertness/Sedation scale (MOAA/S). 30 minutes. | Parental Separation Anxiety scale (PSAS). 30 minutes. | Mask Acceptance Score(MAS). 30 minutes.
Parental Separation Anxiety scale (PSAS).	Modified observer’s Assessment of Alertness/Sedation scale (MOAA/S). 30 minutes. | Parental Separation Anxiety scale (PSAS). 30 minutes. | Mask Acceptance Score(MAS). 30 minutes.

Secondary Outcome Measures

Name	Time	Method
pulse rate, BP, respiratory rate and oxygen saturation were recorded every 10 minute interval for 30 minutes from the time of extubation	pulse rate, BP, respiratory rate and oxygen saturation were recorded every 10 minute interval for 30 minutes from the time of extubation

Trial Locations

Locations (1)

St. Johns Medical College Hospital; 🇮🇳 Bangalore, KARNATAKA, India

St. Johns Medical College Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Rahul Fernandez

Principal investigator

08025631714

rahul.rainmaker@gmail.com