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Completed

NCT Number: NCT00581139

Psychological Influences on Postoperative Recovery

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

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Key information

Conditions

Care, Postoperative Adenoidectomy Neurologic Manifestations Otorhinolaryngologic Surgical Procedures Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Procedures, Operative Tonsillectomy

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale University Department of Anesthesiology

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative Preparation Program (Child Life Specialist)

Behavioral

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

midazolam

Drug

0.5 mg/kg oral midazolam

Other names: Versed

Parental Presence during Induction of Anesthesia

Behavioral

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

PPIA preparation program PLUS Midazolam premedication

Other

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

Primary outcomes

  1. Modified Yale Preoperative Anxiety Scale

    Time frame: Day of surgery

    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.

  2. Percentage of Children Not Exhibiting Negative Behaviors, Fear, or Anxiety (Perfect Induction, 0)

    Time frame: Induction, up to 10 minutes

    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

  3. Percent of Children Crying During Induction

    Time frame: Induction, up to 10 minutes

    Children who were crying/ had tears in their eyes during induction.

  4. Percentage of Children Arriving to PACU Awake

    Time frame: Arrival at PACU, after surgery up to 20 minutes

    Whether child arrived to PACU awake Emergence of 1 // whether child arrived to PACU awake

  5. Percentage of Children Arriving to PACU in Deep Sleep

    Time frame: Arrival at PACU, after surgery up to 20 minutes

    Whether child arrived to PACU awake Emergence of 2 // whether child arrived to PACU in deep sleep

  6. Post Anesthesia Care Unit (PACU) IV Fluid

    Time frame: Post Anesthesia Care Unit up to 2 hours

    Total IV fluid per kg in PACU

  7. Visual Analogue Pain Scale (VAS) 24 Hour After Surgery

    Time frame: 24 Hours 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.

  8. Heart Rate in the General Clinical Research Unit (GCRC)

    Time frame: Hour 0-6 after surgery

    Heart rate was measured in the GCRC by the nurse hours 0 through 6 after Surgery

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

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

Registry information

Acronym: NIH

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Dec 27, 2007
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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