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

NCT01755065 | Completed

• 1 other identifier: PRO12020593
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

laparoscopic surgery; teenager

Outcome Measures

Primary Outcomes (1)

• Post-op pain score

  1 day post-operation

Study Arms (1)

Teenager laparoscopic patients

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 21, 2012
• Study Start: December 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 19, 2017

Record last verified: 2015-04

Locations

US (1)