This trial is evaluating whether Promethazine will improve 1 primary outcome and 3 secondary outcomes in patients with Pruritus. Measurement will happen over the course of Within first 24 hours post cesarean section.
This trial requires 110 total participants across 2 different treatment groups
This trial involves 2 different treatments. Promethazine is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
There is no cure for pruritus. However, many patients with this symptom can alleviate, or eliminate it over time. If symptoms persist, then doctors can help patients manage the problem.
The causes and treatments for pruritus are varied. Topical corticosteroids and the use of antihistamines are common treatments for persistent pruritus. Lifestyle change, dietary modifications, counselling, and counselling for the family are helpful methods of relieving chronic pruritus.
Pruritus is probably the sign of the worst. The hallmark symptom of itch includes burning, tingling, itching, stinging, and scratching. It has been reported by all patients. When pruritus comes under control; this usually will relieve the other symptoms of itch. It is a long way to go, however, before itch disappears. The most important treatment for itch is antipruritic medication. It may be helpful for treating pruritus of other dermatological or non-dermatological origin; however; the effectiveness may be different. It should be used with the consultation of an dermatologist. The effectiveness may be different.
The most common cause of pruritus in the United States is the skin condition rosacea. The second most common cause is itching from eczema with or without other skin conditions. Rosacea and most other causes of itchiness must now be reported because the incidence and severity of itchiness may be improving.
There are many causes of pruritus. Most are benign, but itch can be associated with certain diseases and conditions. The underlying mechanism is generally not known, but is believed to involve sensitization of cutaneous nerves to itching stimuli.\n
In general, pruritus is a severe and troubling symptom that affects patients in many different ways. It can be a diagnostic indicator and can contribute to treatment side effects.
The use of promethazine 4 mg/kg IM is well tolerated and provides improvement in PGE2 and VAS scores. Promethazine appears to be a valuable adjunct to topical antihistamine treatments.
The development of the drug promethazine for itch and other pruritic conditions has been described by a variety of authors over the last 100 years, although it is not clear whether it is effective enough to be a first or second line drug for this use. Promethazine seems to be effective at treating pruritus in some patients but other drugs such as antipsychotics or tetracyclines have shown better results when used first line. A randomized placebo controlled trial addressing the use of antipsychotics in refractory pruritic conditions is warranted.
Results from a recent clinical trial, promethazine is commonly used in combination with other drug(s) to treat pruritus of various causes; however, when promethazine is added to NSAIDs, the pruritus relief is less often seen than in those who have undergone a change to a different drug.
Promethazine has been used widely since the late 1950s. It was never evaluated by the Food and Drug Administration. Its use can cause serious disturbances of cardiac rhythm. These side effects can sometimes be seen in patients who have used promethazine before. Patients who were hospitalized a few days ago are at higher risk of experiencing such side effects due to the delay in the elimination of drug. The use of promethazine should be discontinued before admission.
The authors hypothesize that the promethyazine (PZ) trials are a reflection of promethazine [being used more broadly than topical use] because they would have to be a PZ free study and no other topical promethazine product use. The authors are aware that topical use of promethazine [as a sedative or prophylaxis for allergy in infants] is well documented. The authors also recommend that the reader consult individual references to the promethazine drug label. Promethazine is a weak H receptor agonist. It also blocks the binding site for a number of other compounds, especially narcotics. The authors assert no clinical trial has specifically tested for promethazine.
Promethazine provides a simple and effective treatment for both itching and pain, and hence, there is no need to prescribe a placebo where a safer and more effective drug such as promethazine is available.