A Phase 4 interventional study of Promethazine and Placebo in Pruritus and Pregnancy Related, sponsored by University of Florida. Completed at 1 site in United States. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by University of Florida · Phase 4, Interventional, and Treatment
Neuraxial narcotics are commonly used in obstetric patients for cesarean delivery to help with pain control over the first 24 hours after the surgery. The aim is to evaluate effectiveness of promethazine (IMP) treatment of intrathecal morphine induced pruritus (ITIMIP). A treatment for ITMIP, other than naloxone, will allow for increased use of intrathecal narcotics and decrease the use of systemic opioids in the initial post-operative period.
354 studies on the registry are indexed under Pruritus; 74 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 294 interventional studies indexed under Pruritus.
Browse Pruritus studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Exclusion Criteria:
The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine
Drug: Promethazine
The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride
Drug: Placebo
1cc 25mg/ml Promethazine (study medication)
Also known as: Phenergan
1cc 0.9% Sodium Chloride (placebo)
Also known as: salt water
Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery?
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.
Time frame: Within first 24 hours after cesarean section
Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery?
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.
Time frame: Within first 24 hours post cesarean section
Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline?
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.
Time frame: Within first 24 hours post cesarean section
| Milestone | Promethazine | Placebo |
|---|---|---|
| Started | 36 | 36 |
| Completed | 34 | 33 |
| Not completed | 2 | 3 |
| Withdrew: Study personnel not available | 2 | 0 |
| Withdrew: Spinal anesthesia failure | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 2 |
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.
| Participants | Promethazine | Placebo |
|---|---|---|
| No Itching at 24 hour | 22 | 17 |
| Itching at 24 hour | 10 | 15 |
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.
| Participants | Promethazine | Placebo |
|---|---|---|
| Alert and Calm at 24 hour | 32 | 31 |
| Not Alert and Calm at 24 hour | 0 | 1 |
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.
| Participants | Promethazine | Placebo |
|---|---|---|
| No nausea or vomiting at 24 hours | 31 | 32 |
| Nausea and/or vomiting at 24 hours | 1 | 0 |
Collected over 24 hours after study drug administration. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Promethazine | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Placebo | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
Not recorded
| Age, Categorical(Participants) | Promethazine | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 36 | 36 | 72 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Promethazine | Placebo | Total |
|---|---|---|---|
| Female | 36 | 36 | 72 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Promethazine | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Promethazine | Placebo | Total |
|---|---|---|---|
| United States | 36 | 36 | 72 |
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University of Florida