At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 80 enrolled

Drug / intervention

IV nalbuphine 0.1 mg/kg with induction of anesthesia. +1 moredrug

Likely dose

IV nalbuphine 0.1 mg/kg with induction of anesthesia.from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03470077

NCT03470077Phase 2Completed

Compare CT.gov

Effect of Intravenous Nalbuphine on Emergence Agitation in Children Undergoing Repair of Rupture Globe

Assiut University·interventional·Posted Mar 19, 2018·Updated Sep 2, 2021

In Brief

A Phase 2 clinical trial evaluating IV nalbuphine 0.1 mg/kg with induction of anesthesia. and IV nalbuphine 0.1 mg/kg at the end of surgery. for Postoperative Complications. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPostoperative Complications

CountriesEgypt

Collaborators--

Timeline

Phase 2CompletedFinished

201820192020202120222023202420252026

First PostedMar 2018

Enrollment StartJul 2019

Primary CompletionSep 2020

Study CompletionDec 2020

TodayJul 2026

First PostedMar 19, 2018

Enrollment StartJul 31, 2019

Primary CompletionSep 30, 2020

Study CompletionDec 1, 2020

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 8.3 years ago

Interventions

IV nalbuphine 0.1 mg/kg with induction of anesthesia.drug

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

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

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