Anesthesia Emergence DeliriumNCT03010540

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

A study testing MORPHINE PLUS FENTANYL and Fentanyl in people with Anesthesia Emergence Delirium, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 1 year to 6 years
Conditions the study is for: Anesthesia Emergence Delirium
What is being tested?: MORPHINE PLUS FENTANYL and Fentanyl
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteIndia
Study dates: Jul 2015to Dec 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

ASA 1 Patients Undergoing Cleft Lip And Palate Repair

Who cannot join

CNS Disorders
Respiratory Infection
GERD

Trial locations and contacts

1 site in 1 country.

India1 site

PGIMER
Chandigarh, Punjab, 160012

Other trials in India

About this study

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

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

Conditions: Anesthesia Emergence Delirium
Being tested: MORPHINE PLUS FENTANYL, Fentanyl
Medical subject headings: Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MORPHINE PLUS FENTANYLDrug
Effect Of Morphine Plus Fentanyl On Emergence Delirium
FentanylDrug
Effect Of Fentanyl Only On Emergence Delirium

Study groups in NCT03010540
Study group	Role	What they receive
Morphine Plus Fentanyl	Experimental	Not described Receives: Drug: MORPHINE PLUS FENTANYL
Fentanyl only	Active comparator	Not described Receives: Drug: Fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

Emergence Delirium ( PAED Scale)
Measured: 30 Minutes Postoperatively

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Dec 2016

First posted5 Jan 2017 (estimated)
Study startJul 2015
Primary completionNov 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Anesthesia Emergence DeliriumStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03010540
Sponsor's protocol ID: Emergence delirium
Status last verified: Jan 2017
First submitted: 22 Dec 2016
Last updated: 5 Jan 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability

All Anesthesia Emergence Delirium trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03010540
Acronym / sponsor ID: Emergence delirium
Conditions: Anesthesia Emergence Delirium
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
Study start: Jul 2015
Primary completion: Nov 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 5 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Morphine Plus Fentanyl	Experimental	Drug: MORPHINE PLUS FENTANYL
Fentanyl only	Active comparator	Drug: Fentanyl

Who may qualify

Ages: 1 year to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

ASA 1 Patients Undergoing Cleft Lip And Palate Repair

Key exclusion criteria (3 listed)

CNS Disorders
Respiratory Infection
GERD

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MORPHINE PLUS FENTANYLEffect Of Morphine Plus Fentanyl On Emergence Delirium	Drug	Morphine Plus Fentanyl
FentanylEffect Of Fentanyl Only On Emergence Delirium	Drug	Fentanyl only

Primary outcome

Emergence Delirium ( PAED Scale)
Time frame: 30 Minutes Postoperatively

5 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
Individual participant dataSharing planned: No

Related trials for Anesthesia Emergence Delirium

RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MORPHINE PLUS FENTANYL and Fentanyl in people with Anesthesia Emergence Delirium, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emergence Delirium ( PAED Scale) (time frame: 30 Minutes Postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03010540.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.