At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 241 enrolled

Drug / intervention

Midazolam +3 moredrug

Likely dose

Midazolam 0.5 mg/kgfrom 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/NCT00581139

NCT00581139Phase 2Completed

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Psychological Influences on Postoperative Recovery

University of California, Irvine·interventional·Posted Dec 27, 2007·Updated Sep 7, 2023

In Brief

A Phase 2 clinical trial evaluating Preoperative Preparation Program (Child Life Specialist), Midazolam, and 2 other interventions for Care, Postoperative and 5 related conditions. Completed, enrolled 241 participants across 1 site.

Detailed Summary

The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCare, Postoperative, Pain, Postoperative, Surgical Procedures, Operative, Otorhinolaryngologic Surgical Procedures, Tonsillectomy, Adenoidectomy

CountriesUnited States

CollaboratorsNational Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2003

First PostedDec 2007

Primary CompletionApr 2009

TodayJul 2026

First PostedDec 27, 2007

Enrollment StartApr 1, 2003

Primary CompletionApr 1, 2009

TodayJul 2, 2026

Enrollment to primary: 6 yearsPosted 18.5 years ago

Interventions

Preoperative Preparation Program (Child Life Specialist)behavioral

This group will receive the standard preoperative visit to the hospital with Child Life intervention

Midazolamdrug

0.5 mg/kg oral midazolam

Parental Presence during Induction of Anesthesiabehavioral

One parent will be present during induction of anesthesia of the child. The parent will be accompanied out of the OR by a nurse once the induction is completed. These parents will have completed a parent preparation program.

PPIA preparation program PLUS Midazolam premedicationother

Subjects in this group will receive both interventions 2 and 3.