NCT02022488

Brief Summary

Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children, undergoing urological surgery with sevoflurane anesthesia was included in the study. All the children received oral midazolam 0.5 mg/kg 40 minutes before anesthesia induction then enrolled to one of the study groups, randomly. Ketamine group (Group MK; n=26) patients were given 2mg/kg intranasal ketamine whereas, alfentanil group (Group MA; n=25) were given 10microgram/kg intranasal alfentanil 8-10 min before the induction of anesthesia. Saline group (Group MS; n=27) received intranasal isotonic saline.Parental separation, mask acceptance were evaluated with a 4- point scale. Emergence agitation was evaluated with Pediatric Anesthesia Emergence Delirium score.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
Last Updated

December 30, 2013

Status Verified

December 1, 2013

Enrollment Period

6 months

First QC Date

December 10, 2013

Last Update Submit

December 26, 2013

Conditions

Emergence Agitation

Keywords

ChildSevofluraneEmergence deliriumGeneral anesthesiaPremedication.

Outcome Measures

Primary Outcomes (1)

  • Pediatric Anesthesia Emergence Delirium (PAED) score

    Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score

    7 months

Secondary Outcomes (2)

  • Parental separation score

    7 months

  • Mask acceptance

    7 months

Study Arms (3)

midazolam and alfentanil

ACTIVE COMPARATOR

Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral)

Drug: midazolamDrug: alfentanil

midazolam and ketamine

ACTIVE COMPARATOR

Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal)

Drug: midazolamDrug: ketamine

midazolam

PLACEBO COMPARATOR

Midazolam 0.5mg/kg

Drug: midazolam

Interventions

midazolamDRUG

Group M

midazolammidazolam and alfentanilmidazolam and ketamine
alfentanilDRUG

Group MA

midazolam and alfentanil
ketamineDRUG

Group MK

midazolam and ketamine

Eligibility Criteria

Age1 Year - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years
  • American Society of Anesthesiologist (ASA) I-II,
  • Patients undergoing procedures below the umbilicus

You may not qualify if:

  • cardiac diseases
  • pulmonary diseases
  • hepatic diseases
  • renal diseases
  • psychological or emotional disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University Hospital

Istanbul, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

MidazolamAlfentanilKetamine

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFentanylPiperidinesHeterocyclic Compounds, 1-RingCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yeditepe University

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 27, 2013

Study Start

February 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

December 30, 2013

Record last verified: 2013-12

Locations

TU(1)