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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low pressure pneumoperitoneum | Experimental | Use of low pressure pneumoperitoneum during laparoscopic appendectomy |
|
| Medium pressure pneumoperitoneum | Experimental | Use of medium pressure pneumoperitoneum during laparoscopic appendectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic appendectomy | Procedure | Laparoscopic appendectomy performed with defined, randomized to level of pressure for pneumoperitoneum |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hannah R Neeser, MD | University Children's Hospital of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital Zurich | Zurich | Canton of Zurich | 8032 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24639018 | Background | 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. | |
| 26275545 | Background | 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. |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| D011027 | Pneumoperitoneum |
| D010146 | Pain |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| Through study completion, an average of 3 days |
| 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 |
| Length of operation | Length of operation in minutes | Intraoperative |
| Length of stay | Length of stay in hospital in hours | Through study completion, an average of 3 days |
| Intra- and postoperative complications | Intra- and postoperative complications during hospitalisation | Through study completion, an average of 3 days |
| 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 |
| 18562251 | Background | 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. |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D010532 | Peritoneal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |