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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03010540
Enrollment
70
Registered
2017-01-05
Start date
2015-07-31
Completion date
2016-12-31
Last updated
2017-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Emergence Delirium

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

Interventions

DRUGMORPHINE PLUS FENTANYL

Effect Of Morphine Plus Fentanyl On Emergence Delirium

DRUGFentanyl

Effect Of Fentanyl Only On Emergence Delirium

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

* ASA 1 Patients Undergoing Cleft Lip And Palate Repair

Exclusion criteria

* CNS Disorders * Respiratory Infection * GERD

Design outcomes

Primary

MeasureTime frame
Emergence Delirium ( PAED Scale)30 Minutes Postoperatively

Secondary

MeasureTime frame
Post Operative Pain (FLACC Scale )30 Minutes Postoperatively
Saturation Of Oxygen (SpO2 in %)30 Minutes Postoperatively
Temperature (degree Celsius)30 Minutes Postoperatively
Heart Rate (Beats Per Minute)30 Minutes Postoperatively
Respiratory Rate (Per Minute)30 Minutes Postoperatively

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026