drugset / Trial / NCT04805073
Treatment of Pruritus With Intramuscular Promethazine
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2021-08-09
- Primary completion
- 2024-05-30
- Completion
- 2024-05-30
Publications
- Background Morgan PJ, Mehta S, Kapala DM. Nalbuphine pretreatment in cesarean section patients receiving epidural morphine. Reg Anesth. 1991 Mar-Apr;16(2):84-8.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Promethazine | Small molecule | 25 mg | Intramuscular |