Appendicitis Acute Clinical Trial
— LoMePneuOfficial title:
Postoperative Pain in Children After Low-Pressure Versus Medium-Pressure Pneumoperitoneum in Laparoscopic Surgery
NCT number | NCT04949659 |
Other study ID # | 1001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 27, 2021 |
Est. completion date | June 2025 |
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | June 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Children's Hospital Zurich | Zürich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University Children's Hospital, Zurich |
Switzerland,
Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;2014(3):CD006930. doi: 10.1002/14651858.CD006930.pub3. — View Citation
McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, von Baeyer CL, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L; PedIMMPACT. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain. 2008 Sep;9(9):771-83. doi: 10.1016/j.jpain.2008.04.007. Epub 2008 Jun 17. — View Citation
Ozdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warle MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative pain score on postoperative day one (abdominal pain) | 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. | Postoperative day one. | |
Secondary | Postoperative pain scores during postoperative phase (abdominal pain) | 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. | Through study completion, an average of 3 days | |
Secondary | Postoperative pain scores during postoperative phase (shoulder pain) | 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. | Through study completion, an average of 3 days | |
Secondary | Length of operation | Length of operation in minutes | Intraoperative | |
Secondary | Length of stay | Length of stay in hospital in hours | Through study completion, an average of 3 days | |
Secondary | Intra- and postoperative complications | Intra- and postoperative complications during hospitalisation | Through study completion, an average of 3 days | |
Secondary | Analgesic use | Number and dose (mg/kg) of standard analgesia, as well as so called "rescue" doses | Through study completion, an average of 3 days |
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