Promethazine for Pruritus

Phase-Based Estimates
3
Effectiveness
3
Safety
UF Health at the University of Florida, Gainesville, FL
Pruritus+1 More
Promethazine - Drug
Eligibility
18+
Female
Eligible conditions
Pruritus

Study Summary

Treatment of Pruritus With Intramuscular Promethazine

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Eligible Conditions

  • Pruritus
  • Pregnancy Related

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

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.

Hour 24
Promethazine change in nausea and vomiting
Promethazine does not change pain compared to placebo
Promethazine does not change sedation compared to placebo
Prophylactic intramuscular promethazine does change pruritus in post-partum females that received 100mcg intrathecal morphine

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

Ondansetron
Deep Vein Thrombosis
2%
Fever
2%
Cerebrospinal fluid leak
2%
Cerebrovascular Hematoma
0%
This histogram enumerates side effects from a completed 2013 Phase 4 trial (NCT01474915) in the Ondansetron ARM group. Side effects include: Deep Vein Thrombosis with 2%, Fever with 2%, Cerebrospinal fluid leak with 2%, Cerebrovascular Hematoma with 0%.

Trial Design

2 Treatment Groups

Placebo
Promethazine
Placebo group

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.

Promethazine
Drug
The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine
Placebo
Drug
The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Promethazine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within first 24 hours post cesarean section
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly within first 24 hours post cesarean section for reporting.

Closest Location

UF Health at the University of Florida - Gainesville, FL

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Pregnant adult female patients of at least 18 years of age consenting to a cesarean birth
Willing to consent to study.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can pruritus be cured?

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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.

Unverified Answer

What are common treatments for pruritus?

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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.

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What are the signs of pruritus?

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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.

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How many people get pruritus a year in the United States?

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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.

Unverified Answer

What causes pruritus?

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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

Unverified Answer

What is pruritus?

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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.

Unverified Answer

Does promethazine improve quality of life for those with pruritus?

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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.

Unverified Answer

What are the latest developments in promethazine for therapeutic use?

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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.

Unverified Answer

Is promethazine typically used in combination with any other treatments?

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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.

Unverified Answer

What is promethazine?

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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.

Unverified Answer

Have there been other clinical trials involving promethazine?

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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.

Unverified Answer

Has promethazine proven to be more effective than a placebo?

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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.

Unverified Answer
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