Using dexmeditomidine with midazolam and ketamine, as premedication in children of age group 3-10 years, and comapring their effects.

Not yet recruiting

• Conditions: Patients of age group 3-10 years,undergoing elective surgery under general anesthesia, having ASA 1 & 2

• Registration Number: CTRI/2018/05/013772
• Lead Sponsor: Dr RPGMC Kangra atTanda

Brief Summary

Preoperative period is a stressful event in majority of pediatric individual undergoing surgical procedure. Smooth induction of anesthesia in pediatric patients requires adequate premedication. Nebulization drug delivery is relatively easy and atraumatic mode. It reduces anxiety pain; decreases physical discomfort ; minimizes psychological trauma with a potential for anesthesia. Dexmedetomidine is potent drug and causes dose related sedation by its effect. It has been used in pediatric patients as premedication, as there is no respiratory depression or confusional state. Midazolam and ketamine has also been used as premedication. Ketamine has been used to induce sedation and analgesia in various settings. Midazolam has rapid onset of action and good sedation. All three drugs have their own side effects, respectively. The individual disadvantage of each drug can be counterbalanced when used in combination. The purpose of this study is to compare the efficacy of two nebulized sedation combination regimes of dexmedetomidine-ketamine and dexmedetomidine-midazolam in pediatric patients.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-03-05
• Study Start: 2018-05-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.ASA Class I & II.
• 2.Weight between 8-40 kgs.
• 3.Undergoing elective surgical procedure.

Exclusion Criteria

• 1.Known allergy to the study drug.
• 2.Organ dysfunction.
• 3.Cardiac dysrrhythmia and/or Congenital heart disease.
• 4.Psychotropic medication use and mental retardation.
• 5.History of chronic illness,prematurity,or developmental delay.
• 6.Medical conditions contraindicating the use of drugs like-active GERD, uncontrolled vomiting, recent history of apnea,and active respiratory issues.
• 7.Nasal deformities-spur and deviated nasal septum.
• 8.Uncooperative patients.
• 10.Gut surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare parenteral separation and mask acceptance with ketamine and midazolam when combined with dexmedetomididne repectively, in nebulized form.	4 hours

Secondary Outcome Measures

Name	Time	Method
1.The level of sedation when child is first seen in the operating room.	2.Acceptance of IV cannulation.

Trial Locations

Locations (1)

Dr. Rajendra Prasad Government Medical College; 🇮🇳 Kangra, HIMACHAL PRADESH, India

Dr. Rajendra Prasad Government Medical College

🇮🇳Kangra, HIMACHAL PRADESH, India

Tanvi Dhiman

Principal investigator

7696781240

dr.tanvi90@gmail.com