The Comparison of Different Administration Routes of Pediatric Premedication

Xi'an Jiaotong University

Status and phase: Unknown; Phase 4

Conditions: Anesthesia

Treatments: Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium); Other: Dripping nose; Procedure: Intubation; Other: Intramuscular injection; Other: Oral administration; Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium); Other: Rectal perfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02313337

administration route

Details and patient eligibility

About

The study purpose is to compare the effect of different Administration Routes of Pediatric Premedication (including oral administration, intramuscular injection, rectal perfusion, intranasal).

Full description

In this study, 80 cases of surgical or otolaryngology children undergoing elective surgery were divided into four groups：oral administration group, intramuscular group, rectal infusion group, intranasal group depending on the route of administration before anesthesia. By observing the difference of sedative effects, postoperative recovery, and postoperative psychological behavior among the four groups,compare the effect of four pre-anesthetic administration routes.

Enrollment: 80 estimated patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent of children's parents;
• Children patient in pediatric surgery and E.N.T. department;
• surgery time 1 ~ 3 hours;
• Aged between 1 and 7 years old;
• American Society of Anesthesiologists (ASA)classification:class I~II;

Exclusion criteria

• With cardiovascular and respiratory complications;
• A history of the endocrine system;
• A long history of application of sedative drugs;
• Water and electrolyte balance disorder preoperatively;
• Liver and kidney dysfunction;
• Nervous system dysfunction;
• High gastrointestinal obstruction;
• Tracheoesophageal fistula, trachea foreign body, hiatal hernia, dysphagia;
• Lung infection, atelectasis;
• Congenital heart disease(CHD);
• Severe malnutrition;
• Traumatic or ischemia anoxic encephalopathy, high cranial pressure;
• Anesthesia and surgery was conducted in 3 days;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Oral administration

Experimental group

Description:

-Oral administration of a mixture at preoperative 30 minutes : ketamine 3 mg/kg, midazolam 0.5 mg/kg and atropine 0.02 mg/kg, plus 50% glucose solution to 0.5ml /kg.

Treatment:

Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium)

Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)

Other: Oral administration

Procedure: Intubation

Intramuscular injection

Experimental group

Description:

-At preoperative 30 minutes intramuscular injection of atropine 0.02 mg/kg, 5 minutes before entering the operation room, intramuscular injection of ketamine 5 mg/kg.

Treatment:

Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium)

Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)

Procedure: Intubation

Other: Intramuscular injection

Rectal perfusion

Experimental group

Description:

-At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg

Treatment:

Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium)

Other: Rectal perfusion

Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)

Procedure: Intubation

Dripping nose

Experimental group

Description:

-At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg

Treatment:

Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium)

Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)

Procedure: Intubation

Other: Dripping nose