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Postoperative PainNCT01755065

Clinical Meaning of Visual Analog Scales(VAS) for Teenage Pediatric Patients Undergoing Laparoscopic Surgical Procedures

An observational study of Postoperative Pain, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to find a more accurate postoperative pain assessment for teenager patients. This is important because a patient should not have a very strong pain medication such as morphine if the pain is just mild. Read more about this study

Who is it for?
Ages 11 to 17 years
Conditions the study is for
Postoperative Pain
How many people
206 participants
Where
1 siteUnited States
Study dates
Dec 2012to Nov 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: The participants will be selected based on medical records review and medical interview on the day of surgery: we plan to enroll 206 teenager patients (11-17 years old) with anticipated postoperative pain after any laparoscopic procedure and their parents and nurses.

Who may be able to join

  • 11-17 years old, both male and female
  • the patient is having any laparoscopic surgeries, elective or emergent, including robotic surgeries
  • the patient will be admitted in hospital for at least 23 hours

Who cannot join

  • Patient and family refusal
  • Patient already enrolled in another study
  • Non English-speaking patients and families
  • Cognitive impairment
  • Developmental delay
  • Patients who experienced surgical, anesthesia or medical complications;
Show all 15Show fewer
  • Patients with chronic pain condition (pain more than 3 months)
  • Patients medicated at home or in hospital with long acting opioid pain medication (methadone, oxycontin, oxymorphone ER, morphine slow release)
  • Patients with psychiatric medical history (except attention deficit disorders such us: ADD and ADHD)
  • Patients taking at home the following medication: clonidine, antipsychotic, antidepressant and anxiolytic medications.
  • Patients taking drugs, including smoking marijuana and other recreational drugs
  • Positive pregnancy test
  • Laparoscopic surgical procedures converted to open procedures
  • Patients will be discharged on the day of surgery.
  • If none of the patient's parent will stay with the child during hospital stay, the patient will be not enrolled in the study. If all 8 questionnaires cannot be filled on the day after surgery, the patient will be discontinued from this study.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

Other trials in United States

About this study

Official title: Clinical Meaning of Visual Analog Scales (VAS) for Teenage Pediatric Patients Undergoing Laparoscopic Surgical Procedures

The purpose of this study is to find a more accurate postoperative pain assessment for teenager patients. This is important because a patient should not have a very strong pain medication such as morphine if the pain is just mild.

Read the detailed description

Pain is a sensory and emotional experience, modified by multiple factors, including meaning, context, previous pain experience, culture, gender, expectation, anxiety, depression, fear, family and social factors. Hospitalized teenager patients (11-18 years) admitted to surgical services experience high prevalence of moderate and severe pain.1 The VAS (Visual Analog Scale, 0 mm "no pain", to 100 mm," the worst pain possible ") is used to assess postoperative pain for teenager patients. The reliability and validity of this scale was proven but clinical significance of VAS pain score is not clear. 2 There is an increased focus on very good pain control and is a common practice that patients with moderate or severe pain scores (numeric rating score, more than 4) to receive opioid pain medication 3, regardless of pain behavior or health care providers' input , and this can result in various side effects. Pediatric nurses administer more pain medications to the children who vocalize their pain. 4 Numerous clinical trials of postoperative pain treatment in teenager use only VAS pain scores to assess the effectiveness of a studied pain medication.

Although the treatment of pain may be a basic human right, that does not mean that all teenager patients require opioids administration if they report high pain scores. It is our observation that teenager's pain behavior does not always correlate with the magnitude of reported pain scores by the patient and different caregivers. Concomitant parental and nurse observation of teenager's pain behavior can provide additional information about pain severity. Minimal correlation between VAS pain scores reported by teenager and caregivers does not mean that pain severity is "unreal". Perioperative teenager's pain catastrophizing thoughts about pain, anxiety, and mood level can influence teenager's postoperative pain scores.

The authors aim is to develop a multi-modal assessment of postoperative pain for the teenager patient, using VAS pain scores reported by the teenager, nurse, and parent in association with the teenager's postoperative pain behavior, pain catastrophizing thinking, anxiety, and mood level. The subjects included in this study will be 206 teenager patients (11-17 years old) undergoing any laparoscopic surgical procedures. On postoperative day 1, the teenager will complete the following questionnaires: Visual Analog Scale from teenager (VAS teen), State-Trait Anxiety Inventory for Children (STAIC S - Anxiety), Pain Catastrophizing Scale for Children (PCS-C) and Brief Mood Introspection Scale (BMIS). The nurse taking care of the patient and one parent, preferable the mother, will complete the following questionnaires: Visual Analog Scale from parent (VAS p), Visual Analog Scale from nurse (VAS n), and Adolescent Pain Behavior Questionnaire from parent (APBQ-p), Adolescent Pain Behavior Questionnaire from nurse (APBQ-n). The main goal is to determine if VAS score reported by the teenager correlates with VAS scores reported by the parent and nurse, and with pain behavior scores reported by the nurse and family. Expected correlation is minimal (0.23-0.29) to moderate (0.3-0.49). Our second goal is to determine whether postoperative pain is associated with psychosocial factors such as teenager catastrophizing attention to pain, anxiety, and mood level. Expected correlation between postoperative VAS teen and teenager catastrophizing attention to pain, anxiety, and mood level is moderate (0.3-0.49) to high (>/=0.5).

To our knowledge, this is the first study to investigate all these variables together to assess postoperative pain for a teenager patient. The findings of this study may influence the medical decisions regarding administration of pain medication, allow for a safer and more effective use of opioids in postoperative period and would be very helpful for clinical and research practice.

Keywords
laparoscopic surgery, teenager
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01755065
Study groupRoleWhat they receive
Teenager laparoscopic patientsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-op pain score

    Measured: 1 day post-operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01755065
Sponsor's protocol ID
PRO12020593
Status last verified
Apr 2015
First submitted
19 Dec 2012
Last updated
19 Oct 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pain, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-op pain score (time frame: 1 day post-operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017.

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