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Effect of Intravenous Nalbuphine on Emergence Agitation

NCT03470077 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-09-02

No results posted yet for this study

Summary

Our primary objective of this study is to compare the effect of administration of single dose of intravenous nalbuphine given with induction of anesthesia with intravenous nalbuphine given at the end of surgery on the incidence and severity of EA in children undergoing repair of rupture globe under general anesthesia.

The secondary outcomes will include FLACC score for postoperative pain assessment, hemodynamic variables, any complications as postoperative vomiting (POV) and sedation and parents' satisfaction score.

Conditions

  • Postoperative Complications

Interventions

DRUG

IV nalbuphine 0.1 mg/kg with induction of anesthesia.

Group A: 40 patients will receive IV nalbuphine 0.1 mg/kg with induction of anesthesia. .

DRUG

IV nalbuphine 0.1 mg/kg at the end of surgery.

Group B: 40 patients will receive IV nalbuphine 0.1 mg/kg at the end of surgery just before discontinuation of anesthesia.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Hamdy Abbas, Professor · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2020-09-30
Completion
2020-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03470077 on ClinicalTrials.gov