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

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05245721
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 11.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Agitation, Emergence; Post Operative Pain	Drug: Nalbuphine; Drug: Bupivacain	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Prevention
• Official Title: Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries
• Anticipated Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nalbuphine	Drug: Nalbuphine; Caudal nalbuphine injection in pediatrics undergoing infra-umbilical surgeries; Drug: Bupivacain; Caudal bupivacaine in pediatrics undergoing infra-umbilical surgeries
Active Comparator: Bupivacaine	Drug: Bupivacain; Caudal bupivacaine in pediatrics undergoing infra-umbilical surgeries

Outcome Measures

Primary Outcome Measures

1. Effect of caudal nalbuphine on postoperative emergence agitation according to Pediatric Anasthesia emergence delirium (PAED) [Up to 2 hours postoperative]

   PAED ( The pediatric anesthesia emergence delirium scale)

Secondary Outcome Measures

1. Postoperative pain assessment according to Modified Children's Hospital of Eastern Ontario Pain Scale (modified CHEOPS) [For 24 hours postoperative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rehab Adel Ebrahim Okely, Assistant lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT05245721
• Other Study ID Numbers: 17101501
• First Posted: Feb 18, 2022
• Last Update Posted: Feb 18, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psychomotor Agitation; Emergence Delirium; Pain, Postoperative; Nalbuphine; Bupivacaine

Study Results

No Results Posted as of Feb 18, 2022