NCT02580487

Brief Summary

Acute appendicitis is the most common illness that brings pediatric patients to the hospital for surgical treatment. Abdominal pain is the symptom because of which the patients go to the hospital. Some patients have severe pain and need analgesics before the final diagnosis and before surgery. After surgery most patient experience pain and at least 80 % of the patients need postoperative pain medication. For two decades there has been a clinical guideline for pain management in Kuopio University Hospital (KUH). The investigators aim was to evaluate how well the pain management for pediatric patient works in clinical practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

3.7 years

First QC Date

October 14, 2015

Last Update Submit

October 19, 2015

Conditions

Keywords

acute appendicitispain managementanalgesicspediatric patientslaparoscopyopen surgery

Outcome Measures

Primary Outcomes (1)

  • Pain

    pain is asked preoperatively and at the first postoperative day measured with numeral rating scale

    from preoperative evaluation until the patient left hospital maximum of 7 days

Secondary Outcomes (1)

  • amount of opioids used during hospital stay

    from preoperative evaluation until the patient left hospital maximum of 7 days

Study Arms (2)

retrospective group

Patients whose pain evaluation, analgesics used and details of surgery were collected from patient files

Procedure: appendicectomy

Prospective group

Patients who were interviewed before and after surgery when they were at the hospital

Procedure: appendicectomy

Interventions

Appendix was removed either laparoscopically or open surgery

Prospective groupretrospective group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

152 pediatric patients that were operated on in KUH during the years 2010-2012 due to acute appendicitis. In addition we assessed 26 pediatric appendectomy patients and their pain at rest, when coughing and when compressing the wound area propsectively when they were at hospital

You may qualify if:

  • In prospective patients informed consent obtained
  • Appendectomy performed

You may not qualify if:

  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Location

MeSH Terms

Conditions

AppendicitisAgnosia

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 20, 2015

Study Start

January 1, 2012

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

October 20, 2015

Record last verified: 2015-10

Locations