NCT03010540

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

December 22, 2016

Last Update Submit

January 3, 2017

Conditions

Anesthesia Emergence Delirium

Outcome Measures

Primary Outcomes (1)

  • Emergence Delirium ( PAED Scale)

    30 Minutes Postoperatively

Secondary Outcomes (5)

  • 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

Study Arms (2)

Morphine Plus Fentanyl

EXPERIMENTAL
Drug: MORPHINE PLUS FENTANYL

Fentanyl only

ACTIVE COMPARATOR
Drug: Fentanyl

Interventions

MORPHINE PLUS FENTANYLDRUG

Effect Of Morphine Plus Fentanyl On Emergence Delirium

Morphine Plus Fentanyl
FentanylDRUG

Effect Of Fentanyl Only On Emergence Delirium

Fentanyl only

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA 1 Patients Undergoing Cleft Lip And Palate Repair

You may not qualify if:

  • CNS Disorders
  • Respiratory Infection
  • GERD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIMER

Chandigarh, Punjab, 160012, India

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

MorphineFentanyl

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior Resident, department of Anaesthesia and Intensive Care

Study Record Dates

First Submitted

December 22, 2016

First Posted

January 5, 2017

Study Start

July 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

January 5, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)