Psychological Influences on Postoperative Recovery

Phase 2

Completed

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

• Registration Number: NCT00581139
• Lead Sponsor: University of California, Irvine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2007-12-27
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2021-06-03
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-25
• Last Update Submitted: 2023-08-25
• Results First Posted: 2023-09-07
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2	Midazolam	-
3	Parental Presence during Induction of Anesthesia	-
1	Preoperative Preparation Program (Child Life Specialist)	-
4	PPIA preparation program PLUS Midazolam premedication	-

Primary Outcome Measures

Name	Time	Method
Percentage of Children Arriving to PACU Awake	Arrival at PACU, after surgery up to 20 minutes	Whether child arrived to PACU awake Emergence of 1 // whether child arrived to PACU awake
Percentage of Children Arriving to PACU in Deep Sleep	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
Heart Rate in the General Clinical Research Unit (GCRC)	Hour 0-6 after surgery	Heart rate was measured in the GCRC by the nurse hours 0 through 6 after Surgery
Modified Yale Preoperative Anxiety Scale	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.
Visual Analogue Pain Scale (VAS) 24 Hour After Surgery	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.
Percentage of Children Not Exhibiting Negative Behaviors, Fear, or Anxiety (Perfect Induction, 0)	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
Percent of Children Crying During Induction	Induction, up to 10 minutes	Children who were crying/ had tears in their eyes during induction.
Post Anesthesia Care Unit (PACU) IV Fluid	Post Anesthesia Care Unit up to 2 hours	Total IV fluid per kg in PACU

Trial Locations

Locations (1)

Yale University Department of Anesthesiology; 🇺🇸 New Haven, Connecticut, United States