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Keratoconus is a progressive corneal ectasia that can lead to significant visual impairment and decreased quality of life. The introduction of corneal cross-linking (CXL) with riboflavin and ultraviolet-A (UVA) light has revolutionized the treatment of keratoconus by increasing corneal rigidity and arresting disease progression. The epithelium-off protocol, which induces heightened post-surgical discomfort, is the prevailing approach. Despite the success of CXL, postoperative pain is a common side effect that can negatively impact patients' quality of life and impede recovery.
Pain management after CXL is essential for optimizing patient outcomes and satisfaction. Systemic painkillers, though not researched enough, may potentially aid in healing and recovery, minimizing complications and discomfort for the patient.
In this study we will provide evidence-based recommendations for clinicians to optimize pain control after CXL in collaboration with pain specialists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Active Comparator | This group will receive a combination of drugs including: Gabapentin, NSAIDS and Paracetamol. |
|
| Targin | Active Comparator | This group will receive a combination of drugs including: Targin, NSAIDS and Paracetamol. |
|
| Control | Active Comparator | This group will receive a combination of drugs including: NSAIDS and Paracetamol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Gabapentin 200 mg twice a day, starting from the night prior to the procedure and continue 48 hours after |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain questionnaires | The questionnaire will be asked 2, 6, 24 48 and 72 hours after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shamir Medical Center (Assaf Harofeh) | Be’er Ya‘aqov | 7033001 | Israel |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Targin | Drug | Targin 5 mg twice a day after the procedure for 48 hours |
|
| NSAID | Drug | Nurofen (NSAID) 200 mg twice a day after the procedure for 48 hours |
|
| Paracetamol | Drug | Paracetamol 500 mg every 4 hours during waking hours after the procedure for 48 hours |
|
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |