Emergency intervention for treatment of acute appendicitis in children and adolescents Surgery Emergency intervention for treatment of acute appendicitis in children and adolescents
Conditions
Interventions
As of 19/04/2012 the status of this record was changed to 'stopped' due to low patient recruitment rate. The trial officially stopped on 18/04/2012.
Eligible patients will be randomly
extempore solution) in 5% glucose
2. 0.40% sodium chloride (70 mmol/L Na+ + 45 mmol/L Cl + 25 mmol/L acetate
B. Braun Melsungen AG, Melsungen, Germany) in 2.5% glucose
3. 0.81% sodium chloride (140 mmol/L Na+ + 4 mmol/L K+ + 1 mmol/L Ca2+ + 1 mmol/L Mg2+ + 118 mmol/L Cl + 30 mmol/L acetate
Serumwerk Bernburg AG, Bernburg, Germany) in 1% glucose (the chemical symbols K+, Cl-, Ca2+, and Mg2+ refer to potassium, chloride, calcium, and magnesium, respectively)
The fluid nee
Sponsors
Karolinska University Hospital (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female children and adolescents aged between 1 and 14 years old whose post-operative p-Na+ are within the normal range (local reference range: 135 ? 147 mmol/L) 2. Children and adolescents undergoing emergency intervention for treatment of acute appendicitis either as an open or laparoscopic procedure will be considered to be potentially eligible To qualify for randomisation, the participants are required to have a complicated appendicitis, i.e. gangrenous or perforated, either with generalised or localised peritonitis of such a degree that the surgeon considers oral feeding unsuitable for at least 24 hours following the surgery. Consequently, the randomisation will be performed post-operatively and on the basis of intra-operative findings. We infer that in our study population, the prescription of parenteral fluid therapy for the immediate 24 hours post-operative period might be justified and that by delaying oral fluid therapy intake, in any particular case, will do no harm to the patient.
Exclusion criteria
Exclusion criteria: 1. Any clinical condition, such as renal disease, acute or chronic lung inflammation, pituitary or hypothalamic disease and adrenal insufficiency that eventually can lead to electrolyte and water imbalance 2. Any patient whose p-Na+ is < 130 mmol/L after the initiation of parenteral maintenance fluid therapy, will be withdrawn from the study and treated accordingly at the discretion of the anaesthesiologist responsible for the patient?s care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate whether the post-operative prescription of either hypotonic (0.23% and 0.40% sodium chloride) or near-isotonic (0.81% sodium chloride) fluid therapy given at low maintenance rate in otherwise healthy children with normal post-operative p-Na+ are equally effective in maintaining p-Na+ within the normal range 24 h postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine water and electrolyte-balance during the administration of the investigational parenteral maintenance fluids as well as to investigate known regulatory hormones involved in the homeostatic control of water balance. We will also seek to determine how frequently p-Na+ should be monitored during the 24 h post-operative period. | — |
Countries
Sweden
Outcome results
None listed