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Trial Outcomes & Findings for Treatment of Pruritus With Intramuscular Promethazine (NCT NCT04805073)

NCT ID: NCT04805073

Last Updated: 2025-05-04

Results Overview

Pruritus (itching) will be quantified by the ItchyQuant Scale. The ItchyQuant scale is a 0 -10 scale with 0 denoting no itch and 10, the worst itch possible. Participants were asked at 3 different time points (1 hour, 4 hours and 24 hours) after surgery to rate their itching. In the results here we reported any itching (a score greater than zero on the ItchyQuant scale) at 24 hours after surgery in each group.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

72 participants

Primary outcome timeframe

Within first 24 hours after cesarean section

Results posted on

2025-05-04

Participant Flow

Participant milestones

Participant milestones
Measure
Promethazine
The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine Promethazine: 1cc 25mg/ml Promethazine (study medication)
Placebo
The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride Placebo: 1cc 0.9% Sodium Chloride (placebo)
Overall Study
STARTED
36
36
Overall Study
COMPLETED
34
33
Overall Study
NOT COMPLETED
2
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Promethazine
The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine Promethazine: 1cc 25mg/ml Promethazine (study medication)
Placebo
The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride Placebo: 1cc 0.9% Sodium Chloride (placebo)
Overall Study
study personnel not available
2
0
Overall Study
spinal anesthesia failure
0
1
Overall Study
Lost to Follow-up
0
2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Promethazine
n=36 Participants
The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine Promethazine: 1cc 25mg/ml Promethazine (study medication)
Placebo
n=36 Participants
The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride Placebo: 1cc 0.9% Sodium Chloride (placebo)
Total
n=72 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=72 Participants
Age, Categorical
Between 18 and 65 years
36 Participants
n=36 Participants
36 Participants
n=36 Participants
72 Participants
n=72 Participants
Age, Categorical
>=65 years
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=72 Participants
Sex: Female, Male
Female
36 Participants
n=36 Participants
36 Participants
n=36 Participants
72 Participants
n=72 Participants
Sex: Female, Male
Male
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=72 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
36 participants
n=36 Participants
36 participants
n=36 Participants
72 participants
n=72 Participants

PRIMARY outcome

Timeframe: Within first 24 hours after cesarean section

Population: Sixty-seven patients completed the protocol; of these, 34 received intramuscular promethazine (IMP) and 33 received intramuscular saline placebo (NS). There was incomplete data for 2 patients who received IMP and 1 patient who received NS.

Pruritus (itching) will be quantified by the ItchyQuant Scale. The ItchyQuant scale is a 0 -10 scale with 0 denoting no itch and 10, the worst itch possible. Participants were asked at 3 different time points (1 hour, 4 hours and 24 hours) after surgery to rate their itching. In the results here we reported any itching (a score greater than zero on the ItchyQuant scale) at 24 hours after surgery in each group.

Outcome measures

Outcome measures
Measure
Promethazine
n=32 Participants
The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine Promethazine: 1cc 25mg/ml Promethazine (study medication)
Placebo
n=32 Participants
The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride Placebo: 1cc 0.9% Sodium Chloride (placebo)
Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery?
No Itching at 24 hour
22 Participants
17 Participants
Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery?
Itching at 24 hour
10 Participants
15 Participants

SECONDARY outcome

Timeframe: Within first 24 hours post cesarean section

Level of consciousness will be quantified by the RASS Scale. The RASS scale is scored with +4 to -5 scale with +4=combative, 0=alert and calm and -5=unrousable. Participants were asked at 3 different time points (1 hour, 4 hours and 24 hours) after surgery to rate their level of consciousness. In the results here we reported any score not noted to be 0 (alert and calm) at 24 hours after surgery in each group.

Outcome measures

Outcome measures
Measure
Promethazine
n=32 Participants
The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine Promethazine: 1cc 25mg/ml Promethazine (study medication)
Placebo
n=32 Participants
The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride Placebo: 1cc 0.9% Sodium Chloride (placebo)
Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery?
Alert and Calm at 24 hour
32 Participants
31 Participants
Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery?
Not Alert and Calm at 24 hour
0 Participants
1 Participants

SECONDARY outcome

Timeframe: Within first 24 hours post cesarean section

We asked patients to rate their sensation of nausea and/or vomiting as none, mild, moderate or severe at 4 time points after cesarean (1 hour, 4 hours and 24 hours after cesarean). Here, we rate any report of nausea and/or vomiting as opposed to no nausea and/or vomiting at 24 hours after cesarean among the patients who had Promethazine and normal saline.

Outcome measures

Outcome measures
Measure
Promethazine
n=32 Participants
The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine Promethazine: 1cc 25mg/ml Promethazine (study medication)
Placebo
n=32 Participants
The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride Placebo: 1cc 0.9% Sodium Chloride (placebo)
Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline?
No nausea or vomiting at 24 hours
31 Participants
32 Participants
Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline?
Nausea and/or vomiting at 24 hours
1 Participants
0 Participants

Adverse Events

Promethazine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adam Wendling, MD, Division Chief Obstetric Anesthesiology

University of Florida Health Gainesville

Phone: 3528707461

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place