Effect of Caudal Nalbuphine on Postoperative Emergence Ag... | NCT05245721

Studies
Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries

NCT05245721

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Feb 18, 2022Actual

Enrollment

80Estimated

Phase

Phase 1

Conditions

Agitation, Emergence
Post Operative Pain

Interventions

Nalbuphine
Bupivacain

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2022Estimated

Primary Completion Date

Jan 2023Estimated

Completion Date

Feb 2023Estimated

First Submitted Date

Jan 18, 2022

First Submission Date that Met QC Criteria

Feb 8, 2022

First Posted Date

Feb 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2022

Last Update Posted Date

Feb 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Effect of caudal nalbuphine on postoperative emergence agitation in pediatrics undergoing infra-umbilical surgeries and pain assessment

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nalbuphine	Active Comparator		Drug: Nalbuphine Drug: Bupivacain
Bupivacaine	Active Comparator		Drug: Bupivacain

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nalbuphine	Drug	Caudal nalbuphine injection in pediatrics undergoing infra-umbilical surgeries	Nalbuphine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of caudal nalbuphine on postoperative emergence agitation according to Pediatric Anasthesia emergence delirium (PAED)	PAED ( The pediatric anesthesia emergence delirium scale)	Up to 2 hours postoperative

Secondary Outcomes

Measure	Description	Time Frame
Postoperative pain assessment according to Modified Children's Hospital of Eastern Ontario Pain Scale (modified CHEOPS)		For 24 hours postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 2_12 years
Both genders
ASA I_II
Children undergoing infra-umbilical surgeries

Exclusion Criteria:

Guardians refusal
congenital anomalies at the lower spine or meringues
Increased intracranial pressure
Skin infection at site of injection
Bleeding diathesis
Known allergy to any drugs used

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rehab Adel Ebrahim	Contact	01099070718		Adelrehab273@gmail.com
Mohamed Fathy Mostafa, Assistant professor	Contact	01001123062		mo7_fathy@yahoo.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000071257	Emergence Delirium
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009266	Nalbuphine
D002045	Bupivacaine

Ancestor Terms

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided