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Effect Of Combination of Morphine+Fentanyl on Emergence Delirium in Patients of Cleft Lip and Palate Repair

Primary Purpose

Anesthesia Emergence Delirium

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
MORPHINE PLUS FENTANYL
Fentanyl
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia Emergence Delirium

Eligibility Criteria

1 Year - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA 1 Patients Undergoing Cleft Lip And Palate Repair

Exclusion Criteria:

  • CNS Disorders
  • Respiratory Infection
  • GERD

Sites / Locations

  • PGIMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Morphine Plus Fentanyl

Fentanyl only

Arm Description

Outcomes

Primary Outcome Measures

Emergence Delirium ( PAED Scale)

Secondary Outcome Measures

Post Operative Pain (FLACC Scale )
Saturation Of Oxygen (SpO2 in %)
Temperature (degree Celsius)
Heart Rate (Beats Per Minute)
Respiratory Rate (Per Minute)

Full Information

First Posted
December 22, 2016
Last Updated
January 3, 2017
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT03010540
Brief Title
Effect Of Combination of Morphine+Fentanyl on Emergence Delirium in Patients of Cleft Lip and Palate Repair
Official Title
Emergence Delirium and Recovery Profile in Patients Undergoing Cleft Lip and Palate Repair: Comparison of Combination of Morphine and Fentanyl With Fentanyl Alone
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Emergence Delirium And Recovery Profile In Patients Undergoing Cleft Lip And Cleft Palate Repair With Either Combination Of Morphine Plus Fentanyl Or Fentanyl Alone

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia Emergence Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphine Plus Fentanyl
Arm Type
Experimental
Arm Title
Fentanyl only
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MORPHINE PLUS FENTANYL
Intervention Description
Effect Of Morphine Plus Fentanyl On Emergence Delirium
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Effect Of Fentanyl Only On Emergence Delirium
Primary Outcome Measure Information:
Title
Emergence Delirium ( PAED Scale)
Time Frame
30 Minutes Postoperatively
Secondary Outcome Measure Information:
Title
Post Operative Pain (FLACC Scale )
Time Frame
30 Minutes Postoperatively
Title
Saturation Of Oxygen (SpO2 in %)
Time Frame
30 Minutes Postoperatively
Title
Temperature (degree Celsius)
Time Frame
30 Minutes Postoperatively
Title
Heart Rate (Beats Per Minute)
Time Frame
30 Minutes Postoperatively
Title
Respiratory Rate (Per Minute)
Time Frame
30 Minutes Postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA 1 Patients Undergoing Cleft Lip And Palate Repair Exclusion Criteria: CNS Disorders Respiratory Infection GERD
Facility Information:
Facility Name
PGIMER
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect Of Combination of Morphine+Fentanyl on Emergence Delirium in Patients of Cleft Lip and Palate Repair

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