Appendicitis Acute
Conditions
Keywords
Pneumoperitoneum, Pressure, Pain
Brief summary
The purpose of this study is to asses whether the pressure used for the pneumoperitoneum during laparoscopic surgery in children affects their postoperative pain levels.
Interventions
PROCEDURELaparoscopic appendectomy
Laparoscopic appendectomy performed with defined, randomized to level of pressure for pneumoperitoneum
Sponsors
University Children's Hospital, Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prepped and consented for diagnostic laparoscopy for likely acute appendicitis * 5 years or older * 15 kg or more * Parents/legal custodian give consent, patient shows no signs of unwillingness to participate * Patient is hemodynamically stable
Exclusion criteria
* Clinical signs of four quadrant peritonitis as a clinical sign of perforated appendicitis * Suspected perityphlitic abscess on preoperative ultrasound * Preexisting conditions making postoperative assessment of extent of pain and its localization very difficult or impossible, e.g. conditions that are associated with pronounced developmental delays or with communication difficulties * Parents have inadequate knowledge of German language to understand Informed consent * Child has inadequate knowledge of German language to allow elicitation of Pain Scores
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score on postoperative day one (abdominal pain) | Postoperative day one. | Postoperative pain score for abdominal pain on postoperative day one after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain scores during postoperative phase (abdominal pain) | Through study completion, an average of 3 days | Postoperative pain score for abdominal pain on further postoperative days (excluding day one, which is primary outcome) after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children. |
| Postoperative pain scores during postoperative phase (shoulder pain) | Through study completion, an average of 3 days | Postoperative pain score for shoulder pain during hospitalisation after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children. |
| Length of operation | Intraoperative | Length of operation in minutes |
| Length of stay | Through study completion, an average of 3 days | Length of stay in hospital in hours |
| Intra- and postoperative complications | Through study completion, an average of 3 days | Intra- and postoperative complications during hospitalisation |
| Analgesic use | Through study completion, an average of 3 days | Number and dose (mg/kg) of standard analgesia, as well as so called "rescue" doses |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORHannah R Neeser, MD
University Children's Hospital of Zurich
Outcome results
None listed