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The goal of this clinical trial is to learn if melatonin will decrease pain after C.S. The main questions it aims to answer are:
Does melatonin lower the number of times participants need to use a rescue analgesia? What medical problems do participants have when taking melatonin? Researchers will compare different doses of melatonin to see the ideal dose to decrease pain after C.S.
Participants will:
Take melatonin 30 min before C.S and will be observed for 24 hours for pain and consumption of other analgesia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: (5 mg melatonin) | Active Comparator |
| |
| Group II: (10 mg melatonin) | Active Comparator |
| |
| Group III: (Placebo) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 5 mg | Drug | Group I: (5 mg melatonin): Participants will receive 5 mg of oral melatonin 1 hours before the cesarean section. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity measured using the VAS (Visual Analogue Scale) | it typically consists of a 100 mm straight line with descriptive anchors at each end representing the extremes of the sensation (for example, "no pain" at one end and "the most severe pain imaginable" at the other). Respondents indicate their experience by marking a point on the line, and the distance from the lower anchor is measured and recorded as a continuous variable | 2, 6, 12, and 24 hours post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| first rescue analgesia | Time to first request for analgesia postoperatively | the first 24 hours post operative |
| Total opioid consumption | amount of opioid requested by the patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University Hospital | Recruiting | Banhā | Egypt |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Melatonin 10 mg | Drug | Group II: (10 mg melatonin): Participants will receive 10 mg of oral melatonin 1 hours before the cesarean section. |
|
| Placebo | Drug | Group III: (Placebo): Participants will receive an identical placebo tablet 1 hours before the cesarean section. |
|
| the first 24 hours post operative |
| Incidence of adverse effects | such as nausea, vomiting, headache, dizziness, sedation | first 24 hours post operative |
| Time to first ambulation post-surgery | first movement by the patient | first 24 hours post operative |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |