Effects of Melatonin on Pain Management in Kids After Laparoscopic Surgery
Melatonin and Its Effect on the Perioperative Opioid Needs in Pediatric Patients Undergoing Laparoscopic Surgery.
This study tests if giving melatonin before surgery can help reduce the amount of pain medicine kids aged 2 to 10 need after laparoscopic surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 2 Years to 10 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Abbasia) |
| Trial ID | NCT05728892 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of preoperative melatonin administration on the opioid requirements of pediatric patients undergoing laparoscopic surgeries. By administering either melatonin or a placebo, the researchers aim to evaluate the analgesic and sedative effects of melatonin in children aged 2 to 10 years. The study focuses on patients classified as ASA I and II, ensuring a controlled environment for assessing the outcomes related to postoperative pain management. The findings could provide insights into alternative pain management strategies for young patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2 to 10 years who are classified as ASA I or II and are scheduled for laparoscopic surgery.
Not a fit: Patients with ASA classification III-V, those with a history of allergies to the study medications, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could reduce the need for opioids in pediatric patients after surgery, minimizing potential side effects and improving recovery.
How similar studies have performed: While the specific use of melatonin in this context may be novel, there is existing literature suggesting that melatonin can be effective in managing postoperative pain and sedation in various populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 2 to 10 years. * Sex: Both sexes. * Patients with ASA classificaion I and II. Exclusion Criteria: * Declining to give written informed consent. * History of allergy to the medications used in the study. * psychiatric disorder. * ASA classification III-V. * Fever ,cough , asthma or upper respiratory tract infection, neuromuscular disorders, spine abnormalities. * Anticipated difficult airway . * History of malignant hyperthermia
Where this trial is running
Cairo, Abbasia
- Ain shams university hospital — Cairo, Abbasia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed A Tolba, MD
- Email: Mohamedtolba@med.asu.edu.eg
- Phone: 01156622298
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.