AppendicitisumpikipuNCT02580487
Perioperative Pain Management of Pediatric Appendectomy Patients
An observational study of Appendicitis, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- appendicectomy
- Type of treatment
- Surgery or procedure
- How many people
- 178 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2012to Oct 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- In prospective patients informed consent obtained
- Appendectomy performed
Who cannot join
- No informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Pain Management of Pediatric Appendectomy Patients in Kuopio University Hospital During the Years 2010-2012
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.
- Conditions
- Appendicitis
- Being tested
- appendicectomy
- Keywords
- acute appendicitis, pain management, analgesics, pediatric patients, laparoscopy, open surgery
- Medical subject headings
- Appendicitis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
appendicectomyProcedure or surgery
Appendix was removed either laparoscopically or open surgery
| Study group | Role | What they receive |
|---|---|---|
| retrospective group | Patients whose pain evaluation, analgesics used and details of surgery were collected from patient files Receives: Procedure: appendicectomy | |
| Prospective group | Patients who were interviewed before and after surgery when they were at the hospital Receives: Procedure: appendicectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
pain is asked preoperatively and at the first postoperative day measured with numeral rating scale
Measured: from preoperative evaluation until the patient left hospital maximum of 7 days
Secondary outcomes (1)
amount of opioids used during hospital stay
collected from patient files
Measured: from preoperative evaluation until the patient left hospital maximum of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startJan 2012
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- 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
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merja Kokki, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580487
- Sponsor's protocol ID
- KUH01012012
- Acronym
- umpikipu
- Status last verified
- Oct 2015
- First submitted
- 14 Oct 2015
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Pain Management of Pediatric Appendectomy Patients in Kuopio University Hospital During the Years 2010-2012
- ClinicalTrials.gov ID
- NCT02580487
- Acronym / sponsor ID
- umpikipu / KUH01012012
- Conditions
- Appendicitis
- Keywords
- acute appendicitis, pain management, analgesics, pediatric patients, laparoscopy, open surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Oct 2015 (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.
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.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective group | – | Procedure: appendicectomyPatients whose pain evaluation, analgesics used and details of surgery were collected from patient files |
| Prospective group | – | Procedure: appendicectomyPatients who were interviewed before and after surgery when they were at the hospital |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- In prospective patients informed consent obtained
- Appendectomy performed
Key exclusion criteria (1 listed)
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| appendicectomyAppendix was removed either laparoscopically or open surgery | Procedure or surgery | Prospective group, retrospective group |
Primary outcome
Pain
Time frame: from preoperative evaluation until the patient left hospital maximum of 7 days
pain is asked preoperatively and at the first postoperative day measured with numeral rating scale
1 secondary outcome
amount of opioids used during hospital stay
Time frame: from preoperative evaluation until the patient left hospital maximum of 7 days
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 20 Oct 2015.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
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PAINED: Project Addressing INequities in the Emergency Department
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
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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 Appendicitis, run by Kuopio University Hospital at 1 site in Finland.
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 2 inclusion and 1 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 20 Oct 2015. 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 Finland. 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?
Pain (time frame: from preoperative evaluation until the patient left hospital maximum of 7 days). 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 20 Oct 2015.