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

January 3, 2017 updated by: DR PARUL GUPTA, Postgraduate Institute of Medical Education and Research

Emergence Delirium and Recovery Profile in Patients Undergoing Cleft Lip and Palate Repair: Comparison of Combination of Morphine and Fentanyl With Fentanyl Alone

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • PGIMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1 Patients Undergoing Cleft Lip And Palate Repair

Exclusion Criteria:

  • CNS Disorders
  • Respiratory Infection
  • GERD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Morphine Plus Fentanyl
Drug: MORPHINE PLUS FENTANYL
Effect Of Morphine Plus Fentanyl On Emergence Delirium
ACTIVE_COMPARATOR: Fentanyl only
Drug: Fentanyl
Effect Of Fentanyl Only On Emergence Delirium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Emergence Delirium ( PAED Scale)
Time Frame: 30 Minutes Postoperatively
30 Minutes Postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Post Operative Pain (FLACC Scale )
Time Frame: 30 Minutes Postoperatively
30 Minutes Postoperatively
Saturation Of Oxygen (SpO2 in %)
Time Frame: 30 Minutes Postoperatively
30 Minutes Postoperatively
Temperature (degree Celsius)
Time Frame: 30 Minutes Postoperatively
30 Minutes Postoperatively
Heart Rate (Beats Per Minute)
Time Frame: 30 Minutes Postoperatively
30 Minutes Postoperatively
Respiratory Rate (Per Minute)
Time Frame: 30 Minutes Postoperatively
30 Minutes Postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

January 3, 2017

First Posted (ESTIMATE)

January 5, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 5, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Emergence delirium

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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