Psychological Influences on Postoperative Recovery

Pain, Postoperative Clinical Trial

— NIH  

Official title:

Psychological Influences on Postoperative Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581139
• Other study ID #: 9801009972 [2008-6723]
• Secondary ID: R01HD037007-01
• Status: Completed
• Phase: Phase 2
• Start date: April 2003
• Est. completion date: April 2009

Study information

• Verified date: August 2023
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoidectomy
• Care, Postoperative
• Otorhinolaryngologic Surgical Procedures
• Pain, Postoperative
• Surgical Procedures, Operative
• Tonsillectomy

Intervention

Behavioral:
• Preoperative Preparation Program (Child Life Specialist)
This group will receive the standard preoperative visit to the hospital with Child Life intervention

Drug:
• Midazolam
0.5 mg/kg oral midazolam

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:
• PPIA preparation program PLUS Midazolam premedication
Subjects in this group will receive both interventions 2 and 3.

Locations

Country	Name	City	State
United States	Yale University Department of Anesthesiology	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Percent of Children Crying During Induction	Children who were crying/ had tears in their eyes during induction.	Induction, up to 10 minutes
Primary	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
Primary	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
Primary	Post Anesthesia Care Unit (PACU) IV Fluid	Total IV fluid per kg in PACU	Post Anesthesia Care Unit up to 2 hours
Primary	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
Primary	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