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

Anesthesia Emergence Delirium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010540
• Other study ID #: Emergence delirium
• Status: Completed
• Phase: N/A
• First received: December 22, 2016
• Last updated: January 3, 2017
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 6 Years

Eligibility

Inclusion Criteria:

• ASA 1 Patients Undergoing Cleft Lip And Palate Repair

Exclusion Criteria:

• CNS Disorders

• Respiratory Infection

• GERD

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia Emergence Delirium
• Cleft Lip
• Delirium

Intervention

Drug:
• MORPHINE PLUS FENTANYL
Effect Of Morphine Plus Fentanyl On Emergence Delirium
• Fentanyl
Effect Of Fentanyl Only On Emergence Delirium

Locations

Country	Name	City	State
India	PGIMER	Chandigarh	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergence Delirium ( PAED Scale)		30 Minutes Postoperatively	No
Secondary	Post Operative Pain (FLACC Scale )		30 Minutes Postoperatively	No
Secondary	Saturation Of Oxygen (SpO2 in %)		30 Minutes Postoperatively	No
Secondary	Temperature (degree Celsius)		30 Minutes Postoperatively	No
Secondary	Heart Rate (Beats Per Minute)		30 Minutes Postoperatively	No
Secondary	Respiratory Rate (Per Minute)		30 Minutes Postoperatively	No