AnesthesiaPhase 4NCT02313337

The Comparison of Different Administration Routes of Pediatric Premedication

A Phase 4 study testing Oral administration, Intramuscular injection and Rectal perfusion in people with Anesthesia, run by Second Affiliated Hospital of Xi'an Jiaotong University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

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

Who is it for?: Ages 1 year to 7 years
Conditions the study is for: Anesthesia
What is being tested?: Oral administration, Intramuscular injection and Rectal perfusion
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: Dec 2014to Dec 2015
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 7 years
All sexes
No healthy volunteers
Child

Who may be able to join

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;

Who cannot join

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;

Show all 13Show fewer

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;

About this study

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

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

Read the 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
Being tested: Oral administration, Intramuscular injection, Rectal perfusion, Dripping nose, Anesthesia induction(midazolam,fentanyl,propofol,atracurium)
Keywords: Administration route, Preanesthetic medication, Sedation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral administrationOther
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.
Intramuscular injectionOther
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.
Rectal perfusionOther
Premedicate--At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
Dripping noseOther
Premedicate--At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg
Anesthesia induction(midazolam,fentanyl,propofol,atracurium)Drug
After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .
IntubationProcedure or surgery
Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.
Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)Drug
All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .

Study groups in NCT02313337
Study group	Role	What they receive
Oral administration	Experimental	-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. Receives: Other: Oral administration; Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium); Procedure: Intubation; Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)
Intramuscular injection	Experimental	-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. Receives: Other: Intramuscular injection; Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium); Procedure: Intubation; Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)
Rectal perfusion	Experimental	-At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg Receives: Other: Rectal perfusion; Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium); Procedure: Intubation; Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)
Dripping nose	Experimental	-At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg Receives: Other: Dripping nose; Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium); Procedure: Intubation; Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)

What is being measured

The primary outcome is the main question the study is designed to answer.

Sedation Score
Measured: 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 (4)

Hemodynamic and anesthetic depth monitoring (Heart rate, blood pressure, pulse oxygen saturation, bispectral index(BIS)
Heart rate, blood pressure, pulse oxygen saturation, bispectral index(BIS)
Measured: From premedication to 10 min after extubation up to 4 hours
Stress index monitoring (The concentration of Plasma cortisol and blood sugar)
The concentration of Plasma cortisol and blood sugar
Measured: From anesthesia induction to 10 min after the start of surgery up to 30 min
Postoperation recovery assess (Wake up agitation score (PAED)、Steward score 、Postoperative recovery score)
Wake up agitation score (PAED)、Steward score 、Postoperative recovery score
Measured: 10 min after extubation
Postoperative behavior assessment (Postoperative behavior scale (PHBQ)
Postoperative behavior scale (PHBQ)
Measured: 1 day after the operation，7 day after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Dec 2015

First posted10 Dec 2014 (estimated)
Study startDec 2014
Primary completionDec 2015 (estimated)
Study completionDec 2015 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AnesthesiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02313337
Sponsor's protocol ID: administration route
Status last verified: Nov 2014
First submitted: 27 Nov 2014
Last updated: 10 Dec 2014
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 9830555
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.
PubMed 9024042

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Comparison of Different Administration Routes of Pediatric Premedication-Single Center,Randomized，Controlled Trial
ClinicalTrials.gov ID: NCT02313337
Acronym / sponsor ID: administration route
Conditions: Anesthesia
Keywords: Administration route, Preanesthetic medication, Sedation
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
Study start: Dec 2014
Primary completion: Dec 2015 (estimated)
Study completion: Dec 2015 (estimated)
First posted: 10 Dec 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Oral administration	Experimental	Other: Oral administration, Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium), Procedure: Intubation, Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)-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.
Intramuscular injection	Experimental	Other: Intramuscular injection, Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium), Procedure: Intubation, Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)-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.
Rectal perfusion	Experimental	Other: Rectal perfusion, Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium), Procedure: Intubation, Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)-At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
Dripping nose	Experimental	Other: Dripping nose, Drug: Anesthesia induction(midazolam,fentanyl,propofol,atracurium), Procedure: Intubation, Drug: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)-At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg

Who may qualify

Ages: 1 year to 7 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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;

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral administrationPremedicate--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	Oral administration
Intramuscular injectionPremedicate--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	Intramuscular injection
Rectal perfusionPremedicate--At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg	Other	Rectal perfusion
Dripping nosePremedicate--At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg	Other	Dripping nose
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 .	Drug	Dripping nose, Intramuscular injection, Oral administration, Rectal perfusion
IntubationIntubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.	Procedure or surgery	Dripping nose, Intramuscular injection, Oral administration, Rectal perfusion
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 .	Drug	Dripping nose, Intramuscular injection, Oral administration, Rectal perfusion

Primary outcome

Sedation Score
Time frame: 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

4 secondary outcomes

Hemodynamic and anesthetic depth monitoring (Heart rate, blood pressure, pulse oxygen saturation, bispectral index(BIS)
Time frame: From premedication to 10 min after extubation up to 4 hours
Stress index monitoring (The concentration of Plasma cortisol and blood sugar)
Time frame: From anesthesia induction to 10 min after the start of surgery up to 30 min
Postoperation recovery assess (Wake up agitation score (PAED)、Steward score 、Postoperative recovery score)
Time frame: 10 min after extubation
Postoperative behavior assessment (Postoperative behavior scale (PHBQ)
Time frame: 1 day after the operation，7 day after the operation

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
Background: PubMed 9830555Haas 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.
Background: PubMed 9024042Kain 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.

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"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

NIU XIAOLI principal investigator

The second affiliated hospital of xi 'an jiaotong university

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oral administration, Intramuscular injection and Rectal perfusion in people with Anesthesia, run by Second Affiliated Hospital of Xi'an Jiaotong University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sedation Score (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02313337, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.