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This study aimed to fill the gaps by comparing the efficacy and safety of ondansetron versus metoclopramide for the control of gastroesophageal reflux disorder in children 1-12 months of age, presenting at the outdoor department of Allama Iqbal Teaching Hospital, Dera Ghazi Khan.
Since the FDA issued a warning against domperidone as a potential proarrhythmic drug in children, its use has been widely discouraged and no longer recommended in safe practices. This warning at one end persuaded the pediatricians to search for the new options; on the other end, the use of metoclopramide, H2 receptor antagonists, and alginate-based medications became superfluous, opening a wide area of research in search of the next potential best option. The findings of this study would add to the existing statistics and help clinicians to have better outcomes among infants with gastroesophageal reflux disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoclopramide group | Experimental | Patients were prescribed metoclopramide twice a day for one week. |
|
| Ondansetron | Experimental | Patients in this group were put on oral ondansetron in BD doses for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoclopramide | Drug | Patients were prescribed metoclopramide twice a day for one week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response to treatment | Reduction in vomiting episodes and preservation/increase in previous weight | 1 week |
| Treatment-emerged adverse events | The occurrence of diarrhea, constipation, lethargy/somnolence, dark urine, headache, and warm flushes was considered as treatment-emerged adverse events. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irum Jabeen, FCPS | Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan | Principal Investigator |
| Asma Akbar, FCPS | Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allama Iqbal Teaching Hospital | Dera Ghazi Khan | Punjab Province | 32200 | Pakistan |
If a reasonable request is made, data can be shared.
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| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Ondansetron | Drug | Patients were put on oral ondansetron in BD doses for one week. |
|
| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |