Comparison of drugs for Premedication in the form of popsicles for elective pediatric surgeries.

Recruiting

Conditions: Encounter for routine and ritual male circumcision, (2) ICD-10 Condition: N433||Hydrocele, unspecified, (3) ICD-10 Condition: Q549||Hypospadias, unspecified, (4) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (5) ICD-10 Condition: S829||Unspecified fracture of lower leg,

Registration Number: CTRI/2022/11/047095

Lead Sponsor: Saveetha Medical College Hospital

Brief Summary: **Introduction:** Premedication is widely used in pediatric anesthesia for sedation and anxiolysis. The fear of surgery and anxiety will be present in children and their parents. An ideal premedication should relieve anxiety, facilitate parenteral separation, acceptance of IV cannula and face mask. Its Incidence are higher in pre-school children. Most anesthesiologists use either presence of parent or sedative premedication during induction. Separation from parents and induction of anesthesia are the vital stress factors for children in the perioperative period. A good premedication in pediatric age group should be easy to use, should have rapid onset and short duration of action with less side effects.

**Aim:**To investigate whether combination of midazolam and ketamine in reduced dose as popsicles has the advantages of improved sedation with faster recovery and fewer adverse effects compared to single agents.

**Hypothesis:** Combining midazolam and ketamine in reduced dose as ice cubes will provide better sedation and parenteral separation in pediatric cases when compared to giving separately in regular dose.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 78

Inclusion Criteria

Elective surgeries -Weighing between 10 kgs- 40 kgs -Procedures lasting more than 30 min -ASA I or II patients.

Exclusion Criteria

ASA III or higher, congenital heart defects ,hypo or hyperthyroidism or any other endocrinal disturbances, severe CNS dysfunction, severe liver and renal disease, risk of aspiration, severe systemic illness, Respiratory tract infection (URI/LRTI) -Emergency cases.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the separation anxiety in pediatric patients between the three groups MOKA (Midazolam+Ondansetron+Ketamine+Atropine), MOA (Midazolam+Ondansetron, Atropine), KOA (Ketamine+ Ondansetron+Atropine)	-To assess the parental separation at 10min, 20min, 30min after administration of popsicle \| This is done for all the three groups.

Secondary Outcome Measures

Name	Time	Method
-To compare the Sedation score between the three groups.	-To compare the ease of venous cannulation between the three groups.

Trial Locations

Locations (1): Saveetha Medical College And Hospital
🇮🇳
Chennai, TAMIL NADU, India
Saveetha Medical College And Hospital
🇮🇳Chennai, TAMIL NADU, India
Reesha Joshi
Principal investigator
7094640487
reesha.joshi@gmail.com