Psychological Influences on Postoperative Recovery (NIH)

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 Overview

• Status: Completed
• Conditions: Pain, Postoperative; Care, Postoperative; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Tonsillectomy; Adenoidectomy
• Intervention / Treatment: Behavioral: Preoperative Preparation Program (Child Life Specialist); Drug: Midazolam; Behavioral: Parental Presence during Induction of Anesthesia; Other: PPIA preparation program PLUS Midazolam premedication

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University Department of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Drug: Midazolam; 0.5 mg/kg oral midazolam; Other Names: Versed
Active Comparator: 1	Behavioral: Preoperative Preparation Program (Child Life Specialist); This group will receive the standard preoperative visit to the hospital with Child Life intervention
Active Comparator: 3	Behavioral: Parental Presence during Induction of Anesthesia; 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.; Other Names: PPIA Preparation Program
Active Comparator: 4	Other: PPIA preparation program PLUS Midazolam premedication; Subjects in this group will receive both interventions 2 and 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Yale Preoperative Anxiety Scale	The Modified Yale Preoperative Anxiety Scale (mYPAS) is the current "criterion standard" for assessing child anxiety during induction of anesthesia and has been used in >100 studies. This observational instrument covers 5 items and is typically administered at 4 perioperative time points. Minimum value is 23.33 and maximum value is 100. Scores below 30 are considered low anxiety. Score of 30 or more is considered high anxiety.	Day of surgery
Percentage of Children Not Exhibiting Negative Behaviors, Fear, or Anxiety (Perfect Induction, 0)	A total score is the number of categories checked (1-10). A perfect induction is when a patient does not exhibit negative behaviors, fear, or anxiety. A perfect score would be 0. icc 1 = Crying, tears in eyes icc 2 = Turns head away from mask icc 3 = Verbal refusal, says "no" icc 4 = Verbalization indicating fear or worry, "Where's mommy?" or "Will it hurt?" icc 5 = Pushes mask away with hands, pushes nurse/anesthesiologist with hands/feet icc 6 = Covers mouth/nose with hands/arms or buries face icc 7 = Hysterical crying, may scream icc8 = Kicks/flails legs/arms, arches back, and/or general struggling icc9 = Requires physical restraint icc10 = Complete passivity either rigid or limp icc 0 = Perfect induction	Induction, up to 10 minutes
Percent of Children Crying During Induction	Children who were crying/ had tears in their eyes during induction.	Induction, up to 10 minutes
Percentage of Children Arriving to PACU Awake	Whether child arrived to PACU awake Emergence of 1 // whether child arrived to PACU awake	Arrival at PACU, after surgery up to 20 minutes
Percentage of Children Arriving to PACU in Deep Sleep	Whether child arrived to PACU awake Emergence of 2 // whether child arrived to PACU in deep sleep	Arrival at PACU, after surgery up to 20 minutes
Post Anesthesia Care Unit (PACU) IV Fluid	Total IV fluid per kg in PACU	Post Anesthesia Care Unit up to 2 hours
Visual Analogue Pain Scale (VAS) 24 Hour After Surgery	Parent-ranted child pain on the Visual Analogue Scale. The VAS for pain is a unidimensional measure of pain presented in a horizontal line from 0-100. A higher score indicates greater pain intensity. 0-4= no pain/anxiety, 5-44= mild pain/anxiety, 45-74 = moderate pain/anxiety, 75-100 = severe pain/anxiety.	24 Hours after surgery
Heart Rate in the General Clinical Research Unit (GCRC)	Heart rate was measured in the GCRC by the nurse hours 0 through 6 after Surgery	Hour 0-6 after surgery

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Zeev N Kain, MD, MBA, Yale University Department of Anesthesiology

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: December 18, 2007
• First Submitted That Met QC Criteria: December 26, 2007
• First Posted (Estimated): December 27, 2007

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: 9801009972 [2008-6723]; R01HD037007-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No