NCT02313337

The Comparison of Different Administration Routes of Pediatric Premedication

The Comparison of Different Administration Routes of Pediatric Premedication-Single Center,Randomized，Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 1 Year – 7 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
OTHER	Oral administration	Premedicate--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.
OTHER	Intramuscular injection	Premedicate--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.
OTHER	Rectal perfusion	Premedicate--At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
OTHER	Dripping nose	Premedicate--At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg
DRUG	Anesthesia induction(midazolam,fentanyl,propofol,atracurium)	After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .
PROCEDURE	Intubation	Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.
DRUG	Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)	All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-12-10
• Last updated: 2014-12-10