- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03010540
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
-
-
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
|
Effect Of Morphine Plus Fentanyl On Emergence Delirium
|
ACTIVE_COMPARATOR: Fentanyl only
|
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.
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
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Postoperative Complications
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Congenital Abnormalities
- Stomatognathic Diseases
- Mouth Diseases
- Lip Diseases
- Mouth Abnormalities
- Stomatognathic System Abnormalities
- Delirium
- Emergence Delirium
- Cleft Lip
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Fentanyl
- Morphine
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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