Clinical trial NCT02313337: The Comparison of Different Administration Routes of Pediatric Premedication
Official title: The Comparison of Different Administration Routes of Pediatric Premedication-Single Center,Randomized，Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Keywords: Administration route
Preanesthetic medication
Sedation
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Sedation Score
timeFrame: Try to break away from family membersan，an expected average of 3 min；Successfully break away from the family members and accept the face mask and venipuncture，an expected average of 5 min
Secondary outcomes:
measure: Hemodynamic and anesthetic depth monitoring (Heart rate, blood pressure, pulse oxygen saturation, bispectral index(BIS)
timeFrame: From premedication to 10 min after extubation up to 4 hours
measure: Stress index monitoring (The concentration of Plasma cortisol and blood sugar)
timeFrame: From anesthesia induction to 10 min after the start of surgery up to 30 min
measure: Postoperation recovery assess (Wake up agitation score (PAED)、Steward score 、Postoperative recovery score)
timeFrame: 10 min after extubation
measure: Postoperative behavior assessment (Postoperative behavior scale (PHBQ)
timeFrame: 1 day after the operation，7 day after the operation
Other outcomes:
Locations:
Study officials:
affiliation: The second affiliated hospital of xi 'an jiaotong university
name: NIU XIAOLI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haas U, Motsch J, Schreckenberger R, Bardenheuer HJ, Martin E. [Premedication and preoperative fasting in pediatric anesthesia. Results of a survey]. Anaesthesist. 1998 Oct;47(10):838-43. doi: 10.1007/s001010050633. German.
citation: Kain ZN, Mayes LC, Bell C, Weisman S, Hofstadter MB, Rimar S. Premedication in the United States: a status report. Anesth Analg. 1997 Feb;84(2):427-32. doi: 10.1097/00000539-199702000-00035.