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.
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
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.
- Conditions
- Postoperative Pain
- 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 group | Role | What they receive |
|---|---|---|
| Teenager laparoscopic patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted21 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihaela Visoiu, University of Pittsburgh
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Meaning of Visual Analog Scales (VAS) for Teenage Pediatric Patients Undergoing Laparoscopic Surgical Procedures
- ClinicalTrials.gov ID
- NCT01755065
- Acronym / sponsor ID
- PRO12020593
- Conditions
- Postoperative Pain
- Keywords
- laparoscopic surgery, teenager
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teenager laparoscopic patients | – | – |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- Patient and family refusal
- Patient already enrolled in another study
- Non English-speaking patients and families
- Cognitive impairment
- Developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-op pain score
Time frame: 1 day post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.