Trial · NCT04805073
Treatment of Pruritus With Intramuscular Promethazine
NCT04805073, Phase 4, Completed, University of Florida; results first posted 2025-05-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Pruritus With Intramuscular Promethazine. Trials, record NCT04805073. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04805073
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Pruritus With Intramuscular Promethazine
- NCT number
- NCT04805073
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 72 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Pruritus, Pregnancy Related
- Interventions
- Promethazine, Placebo
- First posted
- 2021-03-18
- Last updated
- 2025-05-04
- Results first posted
- 2025-05-04
- Limitations and caveats
We failed to enroll the planned number of patients due to a variety of factors, including challenges in availability of the study drug coupled with slow enrollment. Over two-thirds of the patients who were screened and were able to be contacted prior to surgery declined to participate. This did not support continuing enrollment.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery? | Within first 24 hours after cesarean section | 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. |
| Secondary | Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery? | 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. |
| Secondary | Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline? | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery? | Within first 24 hours after cesarean section | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery? | Within first 24 hours post cesarean section | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline? | Within first 24 hours post cesarean section | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery? | Promethazine | No Itching at 24 hour | 22 | Participants | |
| Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery? | Placebo | No Itching at 24 hour | 17 | Participants | |
| Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery? | Promethazine | Itching at 24 hour | 10 | Participants | |
| Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery? | Placebo | Itching at 24 hour | 15 | Participants | |
| Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery? | Promethazine | Alert and Calm at 24 hour | 32 | Participants | |
| Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery? | Placebo | Alert and Calm at 24 hour | 31 | Participants | |
| Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery? | Promethazine | Not Alert and Calm at 24 hour | 0 | Participants | |
| Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery? | Placebo | Not Alert and Calm at 24 hour | 1 | Participants | |
| Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline? | Promethazine | No nausea or vomiting at 24 hours | 31 | Participants | |
| Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline? | Placebo | No nausea or vomiting at 24 hours | 32 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Promethazine | 36 | |
| Overall Study | STARTED | Placebo | 36 | |
| Overall Study | COMPLETED | Promethazine | 34 | |
| Overall Study | COMPLETED | Placebo | 33 | |
| Overall Study | NOT COMPLETED | Promethazine | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Promethazine | 0 | 34 |
| Total, all-cause mortality | Placebo | 0 | 33 |
| Total, other adverse events | Promethazine | 0 | 34 |
| Total, other adverse events | Placebo | 0 | 33 |
| Total, serious adverse events | Promethazine | 0 | 34 |
| Total, serious adverse events | Placebo | 0 | 33 |
Source ClinicalTrials.gov
Papers18
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Promethazine vs Placebo: deaths from any cause | Trial comparisons |
| Promethazine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04805073
GET https://conductscience.org/api/trials/v1/NCT04805073/registered