Pruritus, Pregnancy Related
Conditions
Keywords
cesarean section
Brief summary
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.
Interventions
DRUGPromethazine
1cc 25mg/ml Promethazine (study medication)
DRUGPlacebo
1cc 0.9% Sodium Chloride (placebo)
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Stratified randomization design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant adult female patients of at least 18 years of age consenting to a cesarean birth * Willing to consent to study.
Exclusion criteria
* Male patients * Incarceration * Inability to communicate with the investigators * Allergies to any medications used in the study * Possessing any contraindication to spinal anesthesia (lack of consent, elevated intracranial pressure, preexisting neurological disease, thrombocytopenia/coagulopathy, hypovolemia, infection at the site of the procedure) * Patients with an already prolonged QTc (\>500 ms) * Any reason an investigator believes study participation would not be in the best interest of the potential subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Promethazine The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine
Promethazine: 1cc 25mg/ml Promethazine (study medication) | 36 |
| Placebo The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride
Placebo: 1cc 0.9% Sodium Chloride (placebo) | 36 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | spinal anesthesia failure | 0 | 1 |
| Overall Study | study personnel not available | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | Promethazine |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 72 Participants | 36 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 36 participants | 72 participants | 36 participants |
| Sex: Female, Male Female | 36 Participants | 72 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 33 |
| other Total, other adverse events | 0 / 34 | 0 / 33 |
| serious Total, serious adverse events | 0 / 34 | 0 / 33 |
Outcome results
Primary
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
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Promethazine | Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery? | No Itching at 24 hour | 22 Participants |
| Promethazine | Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery? | Itching at 24 hour | 10 Participants |
| Placebo | Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery? | No Itching at 24 hour | 17 Participants |
| Placebo | Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery? | Itching at 24 hour | 15 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Promethazine | Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline? | No nausea or vomiting at 24 hours | 31 Participants |
| Promethazine | Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline? | Nausea and/or vomiting at 24 hours | 1 Participants |
| Placebo | Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline? | No nausea or vomiting at 24 hours | 32 Participants |
| Placebo | Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline? | Nausea and/or vomiting at 24 hours | 0 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Promethazine | Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery? | Alert and Calm at 24 hour | 32 Participants |
| Promethazine | Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery? | Not Alert and Calm at 24 hour | 0 Participants |
| Placebo | Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery? | Alert and Calm at 24 hour | 31 Participants |
| Placebo | Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery? | Not Alert and Calm at 24 hour | 1 Participants |