PruritusPhase 4NCT04805073

Treatment of Pruritus With Intramuscular Promethazine

A Phase 4 study testing Promethazine in people with Pruritus and Pregnancy Related, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 99 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pruritus, Pregnancy Related
What is being tested?: Promethazine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 1 siteUnited States
Study dates: 9 Aug 2021to 30 May 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Pregnant adult female patients of at least 18 years of age consenting to a cesarean birth
Willing to consent to study.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

UF Health at the University of Florida
Gainesville, Florida, 32610

Other trials in United States

About this study

Official title: Assessing Efficacy of Intramuscular Promethazine for the Treatment of Intrathecal Morphine Induced Pruritus

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.

Conditions: Pruritus, Pregnancy Related
Being tested: Promethazine, Placebo
Keywords: cesarean section
Medical subject headings: Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PromethazineDrug
Also called Phenergan
1cc 25mg/ml Promethazine (study medication)
PlaceboDrug
Also called salt water
1cc 0.9% Sodium Chloride (placebo)

Study groups in NCT04805073
Study group	Role	What they receive
Promethazine	Experimental	The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine Receives: Drug: Promethazine
Placebo	Placebo comparator	The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Within first 24 hours after cesarean section

Secondary outcomes (2)

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.
Measured: 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.
Measured: Within first 24 hours post cesarean section

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Aug 202130 May 2024

First posted18 Mar 2021
Study start9 Aug 2021
Primary completion30 May 2024
Study completion30 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (18)Papers the sponsor has linked to this study.
Other trials for PruritusStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04805073
Sponsor's protocol ID: IRB202002297-A
Other IDs: OCR40099
Status last verified: Apr 2025
First submitted: 15 Mar 2021
Last updated: 4 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Morgan PJ, Mehta S, Kapala DM. Nalbuphine pretreatment in cesarean section patients receiving epidural morphine. Reg Anesth. 1991 Mar-Apr;16(2):84-8.
PubMed 2043531
Cohen SE, Ratner EF, Kreitzman TR, Archer JH, Mignano LR. Nalbuphine is better than naloxone for treatment of side effects after epidural morphine. Anesth Analg. 1992 Nov;75(5):747-52.
PubMed 1416128
Vice-O'Con K, Austin PN, Pugh MA. Pharmacologic Methods for Preventing Pruritus in Patients Receiving Intrathecal Opioids for Cesarean Delivery. AANA J. 2018 Feb;86(1):59-66.
PubMed 31573495
Penning JP, Samson B, Baxter AD. Reversal of epidural morphine-induced respiratory depression and pruritus with nalbuphine. Can J Anaesth. 1988 Nov;35(6):599-604. doi: 10.1007/BF03020347.
PubMed 3144443
Alhashemi JA, Crosby ET, Grodecki W, Duffy PJ, Hull KA, Gallant C. Treatment of intrathecal morphine-induced pruritus following caesarean section. Can J Anaesth. 1997 Oct;44(10):1060-5. doi: 10.1007/BF03019227.
PubMed 9350364
Ituk U, Habib AS. Enhanced recovery after cesarean delivery. F1000Res. 2018 Apr 27;7:F1000 Faculty Rev-513. doi: 10.12688/f1000research.13895.1. eCollection 2018.
PubMed 29770203
Singh PM, Sultan P, O'Carroll J, Blake L, Carvalho B, Singh NP, Monks DT. Pharmacological agents for prevention of pruritus in women undergoing Caesarean delivery with neuraxial morphine: a systematic review and Bayesian network meta-analysis. Br J Anaesth. 2023 Sep;131(3):556-571. doi: 10.1016/j.bja.2023.05.028. Epub 2023 Jul 14.
PubMed 37455197
Moustafa AA, Baaror AS, Abdelazim IA. Comparative study between nalbuphine and ondansetron in prevention of intrathecal morphine-induced pruritus in women undergoing cesarean section. Anesth Essays Res. 2016 May-Aug;10(2):238-44. doi: 10.4103/0259-1162.167839.
PubMed 27212754
Charuluxananan S, Somboonviboon W, Kyokong O, Nimcharoendee K. Ondansetron for treatment of intrathecal morphine-induced pruritus after cesarean delivery. Reg Anesth Pain Med. 2000 Sep-Oct;25(5):535-9. doi: 10.1053/rapm.2000.7809.
PubMed 11009242
Sultan P, Halpern SH, Pushpanathan E, Patel S, Carvalho B. The Effect of Intrathecal Morphine Dose on Outcomes After Elective Cesarean Delivery: A Meta-Analysis. Anesth Analg. 2016 Jul;123(1):154-64. doi: 10.1213/ANE.0000000000001255.
PubMed 27089000
Kumar K, Singh SI. Neuraxial opioid-induced pruritus: An update. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):303-7. doi: 10.4103/0970-9185.117045.
PubMed 24106351
Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993 May;168(5):1393-9. doi: 10.1016/s0002-9378(11)90771-6.
PubMed 8498418
Anwari JS, Iqbal S. Antihistamines and potentiation of opioid induced sedation and respiratory depression. Anaesthesia. 2003 May;58(5):494-5. doi: 10.1046/j.1365-2044.2003.03154_18.x. No abstract available.
PubMed 12694022
Eldor J, Fishelev V, Levine S, Guedj P, Dudakova I. Prevention of epidural morphine pruritus by intramuscular promethazine in parturients. Reg Anesth. 1994 Nov-Dec;19(6):433-4. No abstract available.
PubMed 7848959
Slappendel R, Weber EW, Benraad B, van Limbeek J, Dirksen R. Itching after intrathecal morphine. Incidence and treatment. Eur J Anaesthesiol. 2000 Oct;17(10):616-21. doi: 10.1046/j.1365-2346.2000.00727.x.
PubMed 11050519

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
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RecruitingPhase 3
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All Pruritus trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing Efficacy of Intramuscular Promethazine for the Treatment of Intrathecal Morphine Induced Pruritus
ClinicalTrials.gov ID: NCT04805073
Acronym / sponsor ID: IRB202002297-A
Conditions: Pruritus, Pregnancy Related
Keywords: cesarean section
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Study start: 9 Aug 2021 (actual)
Primary completion: 30 May 2024 (actual)
Study completion: 30 May 2024 (actual)
First posted: 18 Mar 2021 (actual)
Results: Posted 4 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Promethazine	Experimental	Drug: PromethazineThe treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine
Placebo	Placebo comparator	Drug: PlaceboThe treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride

Who may qualify

Ages: 18 to 99 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Pregnant adult female patients of at least 18 years of age consenting to a cesarean birth
Willing to consent to study.

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PromethazineAlso: Phenergan1cc 25mg/ml Promethazine (study medication)	Drug	Promethazine
PlaceboAlso: salt water1cc 0.9% Sodium Chloride (placebo)	Drug	Placebo

Primary outcome

Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery?
Time frame: 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.

2 secondary outcomes

Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery?
Time frame: Within first 24 hours post cesarean section
Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline?
Time frame: Within first 24 hours post cesarean section

Results and safety

Results posted to the registry on 4 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Promethazine	36	34
Placebo	36	33

Primary outcome: Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery?

Time frame: Within first 24 hours after cesarean section. Count of participants. Unit: Participants

Measure	Promethazine n = 32	Placebo n = 32
No Itching at 24 hour	22	17
Itching at 24 hour	10	15

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 hours after study drug administration. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Promethazine	0 of 34 (0%)	0 of 34 (0%)	0 of 34
Placebo	0 of 33 (0%)	0 of 33 (0%)	0 of 33

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 2043531Morgan PJ, Mehta S, Kapala DM. Nalbuphine pretreatment in cesarean section patients receiving epidural morphine. Reg Anesth. 1991 Mar-Apr;16(2):84-8.
Background: PubMed 1416128Cohen SE, Ratner EF, Kreitzman TR, Archer JH, Mignano LR. Nalbuphine is better than naloxone for treatment of side effects after epidural morphine. Anesth Analg. 1992 Nov;75(5):747-52.
Background: PubMed 31573495Vice-O'Con K, Austin PN, Pugh MA. Pharmacologic Methods for Preventing Pruritus in Patients Receiving Intrathecal Opioids for Cesarean Delivery. AANA J. 2018 Feb;86(1):59-66.
Background: PubMed 3144443Penning JP, Samson B, Baxter AD. Reversal of epidural morphine-induced respiratory depression and pruritus with nalbuphine. Can J Anaesth. 1988 Nov;35(6):599-604. doi: 10.1007/BF03020347.
Background: PubMed 9350364Alhashemi JA, Crosby ET, Grodecki W, Duffy PJ, Hull KA, Gallant C. Treatment of intrathecal morphine-induced pruritus following caesarean section. Can J Anaesth. 1997 Oct;44(10):1060-5. doi: 10.1007/BF03019227.
Background: PubMed 29770203Ituk U, Habib AS. Enhanced recovery after cesarean delivery. F1000Res. 2018 Apr 27;7:F1000 Faculty Rev-513. doi: 10.12688/f1000research.13895.1. eCollection 2018.
Background: PubMed 37455197Singh PM, Sultan P, O'Carroll J, Blake L, Carvalho B, Singh NP, Monks DT. Pharmacological agents for prevention of pruritus in women undergoing Caesarean delivery with neuraxial morphine: a systematic review and Bayesian network meta-analysis. Br J Anaesth. 2023 Sep;131(3):556-571. doi: 10.1016/j.bja.2023.05.028. Epub 2023 Jul 14.
Background: PubMed 27212754Moustafa AA, Baaror AS, Abdelazim IA. Comparative study between nalbuphine and ondansetron in prevention of intrathecal morphine-induced pruritus in women undergoing cesarean section. Anesth Essays Res. 2016 May-Aug;10(2):238-44. doi: 10.4103/0259-1162.167839.
Background: PubMed 11009242Charuluxananan S, Somboonviboon W, Kyokong O, Nimcharoendee K. Ondansetron for treatment of intrathecal morphine-induced pruritus after cesarean delivery. Reg Anesth Pain Med. 2000 Sep-Oct;25(5):535-9. doi: 10.1053/rapm.2000.7809.
Background: PubMed 27089000Sultan P, Halpern SH, Pushpanathan E, Patel S, Carvalho B. The Effect of Intrathecal Morphine Dose on Outcomes After Elective Cesarean Delivery: A Meta-Analysis. Anesth Analg. 2016 Jul;123(1):154-64. doi: 10.1213/ANE.0000000000001255.
Background: PubMed 24106351Kumar K, Singh SI. Neuraxial opioid-induced pruritus: An update. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):303-7. doi: 10.4103/0970-9185.117045.
Background: PubMed 8498418Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993 May;168(5):1393-9. doi: 10.1016/s0002-9378(11)90771-6.
Individual participant dataSharing planned: No

Related trials for Pruritus

Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
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Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
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Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
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RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adam Wendling, MD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Promethazine in people with Pruritus and Pregnancy Related, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery? (time frame: Within first 24 hours after cesarean section). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04805073, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.