CClinicalTrials.gg
Status unknownNCT05245721Updated Feb 18, 2022

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

A Phase 1 interventional study of Nalbuphine and Bupivacain in Agitation, Emergence and Post Operative Pain, sponsored by Assiut University. Status unknown. Open to participants aged 2 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-18.

Sponsored by Assiut University · Phase 1, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
2 Years to 12 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Agitation, Emergence
  • Post Operative Pain
03

In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's planned enrollment of 80 is below the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.

Browse Psychomotor Agitation studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Nalbuphine

    Drug: Nalbuphine · Drug: Bupivacain

  • Active comparator
    Bupivacaine

    Drug: Bupivacain

Interventions

  • DrugNalbuphine

    Caudal nalbuphine injection in pediatrics undergoing infra-umbilical surgeries

  • DrugBupivacain

    Caudal bupivacaine in pediatrics undergoing infra-umbilical surgeries

06

What researchers measure

Primary outcomes

  1. Effect of caudal nalbuphine on postoperative emergence agitation according to Pediatric Anasthesia emergence delirium (PAED)

    PAED ( The pediatric anesthesia emergence delirium scale)

    Time frame: Up to 2 hours postoperative

Secondary outcomes

  1. Postoperative pain assessment according to Modified Children's Hospital of Eastern Ontario Pain Scale (modified CHEOPS)

    Time frame: For 24 hours postoperative

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05245721
Lead sponsor
Assiut University
Responsible party
Rehab Adel Ebrahim Okely (Assistant lecturer, Assiut University) — Principal investigator
First posted
Feb 18, 2022
Start date
Mar 2022 (estimated)
Primary completion
Jan 2023 (estimated)
Completion
Feb 2023 (estimated)
Last update
Feb 18, 2022

Study contacts

Rehab Adel Ebrahim
Contact
Adelrehab273@gmail.com
01099070718
Mohamed Fathy Mostafa, Assistant professor
Contact
mo7_fathy@yahoo.com
01001123062

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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