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Study on Pain Management in Children Aged 7-18 with Acute Appendicitis Using Ketorolac Trometamol

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What is this study about?

This clinical trial focuses on studying uncomplicated acute appendicitis in children aged 7 to 18 years. Acute appendicitis is a condition where the appendix, a small organ attached to the large intestine, becomes inflamed and painful. In this study, the treatment being used is a medication called Ketorolac, which is given as an injection. Ketorolac is a type of pain reliever that helps reduce pain and inflammation.

The purpose of the study is to examine how well Ketorolac works in managing pain and other clinical and biochemical factors in children with uncomplicated acute appendicitis who are receiving non-surgical treatment. The study aims to develop a pain management plan based on the findings. Participants will receive the treatment and be monitored for their pain levels and other health indicators over a period of three days.

During the study, some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Ketorolac. The study will help researchers understand the effectiveness of Ketorolac in treating pain associated with uncomplicated acute appendicitis in children, potentially leading to better pain management strategies in the future.

1 joining the study

Children aged 7 to 18 years with a first-time diagnosis of uncomplicated acute appendicitis are eligible to join the study. The study focuses on non-surgical treatment.

2 initial assessment

An initial assessment is conducted to evaluate the pain syndrome and clinical-biochemical parameters. This assessment helps in understanding the current condition and planning the treatment.

3 medication administration

The medication used in the study is ketorolac trometamol, administered as a solution for injection. The concentration is 30 mg/ml. The specific dosage and frequency are determined based on individual needs and medical guidelines.

4 pain assessment

Pain assessment is conducted at various time points over a period of 3 days (72 hours). This helps in monitoring the effectiveness of the treatment and adjusting it if necessary.

5 monitoring and data collection

Throughout the study, clinical and biochemical parameters are monitored. This data is crucial for developing an analgesic algorithm based on the findings.

6 completion of study participation

Participation in the study concludes after the final assessments are completed. The study aims to gather comprehensive data to improve treatment strategies for uncomplicated acute appendicitis in children.

Who Can Join the Study?

  • Children aged between 7 and 18 years old.
  • Must have been diagnosed for the first time with uncomplicated acute appendicitis. This means the appendix is inflamed but hasn’t caused severe complications.
  • Must have received non-surgical treatment. This means the condition was managed without surgery, possibly with medication or other methods.
  • Both boys and girls can participate.

Who Cannot Join the Study?

  • Patients with a different condition than uncomplicated acute appendicitis cannot participate. This means if the appendicitis is severe or has complications, the patient is not eligible.
  • Patients younger than 7 years old or older than 18 years old are not eligible to participate.
  • Patients who are not able to follow the study procedures or instructions cannot participate.
  • Patients who have other medical conditions that might interfere with the study results are not eligible.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Patients who have allergies or reactions to the medications used in the study cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible to participate.

Where you can join this trial?

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Site Name City Country Status
Bmzbz Kjnayyxc Ulhapnuwvpxwy Sqgoqnyx Vahz Riga Latvia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Latvia Latvia
Not yet recruiting
05.07.2021

Trial locations

Investigated drugs:

Antibiotics are used in this study to treat uncomplicated acute appendicitis in children without surgery. They help to reduce infection and inflammation in the appendix, allowing the body to heal naturally.

Pain Relievers are included in the trial to manage and reduce pain associated with acute appendicitis. These medications help improve comfort and quality of life for the children during their recovery process.

Investigated diseases:

Uncomplicated Acute Appendicitis – This condition involves inflammation of the appendix, a small pouch attached to the large intestine. It typically presents with sudden pain in the lower right abdomen, which may start around the navel and then shift. The pain often worsens with movement, coughing, or sneezing. Other symptoms can include nausea, vomiting, and a low-grade fever. In uncomplicated cases, the appendix has not burst or formed an abscess. The condition is usually diagnosed based on symptoms and physical examination.

Trial ID:
2025-520964-16-00
Trial Phase:
Human Pharmacology (Phase I) – Other

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