Comparing low and medium pressure during laparoscopic surgery for appendicitis in children
Postoperative Pain in Children After Low-Pressure Versus Medium-Pressure Pneumoperitoneum in Laparoscopic Surgery
This study tests if using lower air pressure during laparoscopic surgery for appendicitis in kids can help them feel less pain afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 1 site (Zürich, Zurich) |
| Trial ID | NCT04949659 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of different pneumoperitoneum pressures on postoperative pain levels in children undergoing laparoscopic appendectomy. It involves children aged 5 years and older who are scheduled for surgery due to suspected acute appendicitis. The study aims to determine whether using lower pressure during the procedure can lead to reduced pain after surgery. Participants will be monitored for pain levels postoperatively to assess the effectiveness of the pressure variations.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 years and older, weighing at least 15 kg, who are scheduled for laparoscopic surgery for suspected acute appendicitis.
Not a fit: Patients with signs of perforated appendicitis or significant communication difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for children undergoing laparoscopic surgery.
How similar studies have performed: While studies on pneumoperitoneum pressures exist, this specific comparison in a pediatric population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zürich, Zurich
- University Children's Hospital Zurich — Zürich, Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Hannah R Neeser, MD — University Children's Hospital of Zurich
- Study coordinator: Hannah R Neeser, MD
- Email: Hannah.Neeser@kispi.uzh.ch
- Phone: +41442667045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.