Phase 2 N=241 Randomized Prevention

Psychological Influences on Postoperative Recovery

Care, Postoperative · Pain, Postoperative · Surgical Procedures, Operative · Otorhinolaryngologic Surgical Procedures · Tonsillectomy

Bottom Line

View on ClinicalTrials.gov: NCT00581139 ↗

Enrolled (actual)

241

Serious AEs

0.0%

Results posted

Sep 2023

Primary outcome: Primary: Modified Yale Preoperative Anxiety Scale — 41.59; 37.44; 46.17; 33.65 Score on mYPAS scale — p=.02

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Preoperative Preparation Program (Child Life Specialist) (Behavioral); Midazolam (Drug); Parental Presence during Induction of Anesthesia (Behavioral); PPIA preparation program PLUS Midazolam premedication (Other)
Age: Pediatric · 3+ yrs
Sex: All
Sponsor: University of California, Irvine
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Modified Yale Preoperative Anxiety Scale	41.59; 37.44; 46.17; 33.65	.02 sig
PRIMARY Percentage of Children Not Exhibiting Negative Behaviors, Fear, or Anxiety (Perfect Induction, 0)	68; 83; 62; 86	—
PRIMARY Percent of Children Crying During Induction	32; 17; 38; 14	.01 sig
PRIMARY Percentage of Children Arriving to PACU Awake	55; 32; 32; 33	.01 sig
PRIMARY Percentage of Children Arriving to PACU in Deep Sleep	45; 68; 46; 67	.01 sig
PRIMARY Post Anesthesia Care Unit (PACU) IV Fluid	13.18; 16.85; 18.78; 22.21	.02 sig
PRIMARY Visual Analogue Pain Scale (VAS) 24 Hour After Surgery	34.13; 35.93; 38.30; 47.02	.04 sig
PRIMARY Heart Rate in the General Clinical Research Unit (GCRC)	96.75; 95.13; 97.39; 104.55	.04 sig

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.

Eligibility Criteria

Inclusion Criteria

Outpatient tonsillectomy or tonsils/adenoids
ASA I, II

Exclusion Criteria

Developmental delay
ASA III-IV
Psychotropic medication
Meds which interfere with metabolism of midazolam
36 weeks gestation

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Data sourced from ClinicalTrials.gov (NCT00581139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.