Treatment of Pruritus With Intramuscular Promethazine

NCT04805073 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IRB202002297-AOCR40099
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Pruritus; Pregnancy Related

Keywords

cesarean section

Outcome Measures

Primary Outcomes (1)

• 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.

  Within first 24 hours after cesarean section

Secondary Outcomes (2)

• Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery?

  Within first 24 hours post cesarean section

• Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline?

  Within first 24 hours post cesarean section

Study Arms (2)

Promethazine

EXPERIMENTAL

The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine

Drug: Promethazine

Placebo

PLACEBO COMPARATOR

The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride

Drug: Placebo

Interventions

Promethazine DRUG

1cc 25mg/ml Promethazine (study medication)

Also known as: Phenergan

Promethazine

Placebo DRUG

1cc 0.9% Sodium Chloride (placebo)

Also known as: salt water

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Pregnant adult female patients of at least 18 years of age consenting to a cesarean birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (18)

• Morgan PJ, Mehta S, Kapala DM. Nalbuphine pretreatment in cesarean section patients receiving epidural morphine. Reg Anesth. 1991 Mar-Apr;16(2):84-8.

  PMID: 2043531 BACKGROUND

• 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.

  PMID: 1416128 BACKGROUND

• 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.

  PMID: 31573495 BACKGROUND

• 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.

  PMID: 3144443 BACKGROUND

• 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.

  PMID: 9350364 BACKGROUND

• 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.

  PMID: 29770203 BACKGROUND

• 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.

  PMID: 37455197 BACKGROUND

• 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.

  PMID: 27212754 BACKGROUND

• 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.

  PMID: 11009242 BACKGROUND

• 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.

  PMID: 27089000 BACKGROUND

• 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.

  PMID: 24106351 BACKGROUND

• 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.

  PMID: 8498418 BACKGROUND

• 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.

  PMID: 12694022 BACKGROUND

• 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.

  PMID: 7848959 RESULT

• 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.

  PMID: 11050519 RESULT

• Horta ML, Morejon LC, da Cruz AW, Dos Santos GR, Welling LC, Terhorst L, Costa RC, Alam RU. Study of the prophylactic effect of droperidol, alizapride, propofol and promethazine on spinal morphine-induced pruritus. Br J Anaesth. 2006 Jun;96(6):796-800. doi: 10.1093/bja/ael072. Epub 2006 Apr 5.

  PMID: 16597655 RESULT

• Haydek CG, Love E, Mollanazar NK, Valdes Rodriguez R, Lee H, Yosipovitch G, Tharp MD, Hanifin JM, Chen KH, Chen SC. Validation and Banding of the ItchyQuant: A Self-Report Itch Severity Scale. J Invest Dermatol. 2017 Jan;137(1):57-61. doi: 10.1016/j.jid.2016.06.633. Epub 2016 Aug 10.

  PMID: 27521593 RESULT

• Koju RB, Gurung BS, Dongol Y. Prophylactic administration of ondansetron in prevention of intrathecal morphine-induced pruritus and post-operative nausea and vomiting in patients undergoing caesarean section. BMC Anesthesiol. 2015 Feb 17;15:18. doi: 10.1186/1471-2253-15-18.

  PMID: 25971957 RESULT

MeSH Terms

Conditions

Pruritus

Interventions

Promethazine; Fluoridation

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Preventive Dentistry; Dentistry; Public Health Dentistry; Environment and Public Health

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.

Results Point of Contact

• Title: Adam Wendling, MD, Division Chief Obstetric Anesthesiology
• Organization: University of Florida Health Gainesville

Awendling@anest.ufl.edu

3528707461

Study Officials

• Adam Wendling, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Stratified randomization design
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 18, 2021
• Study Start: August 9, 2021
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)