Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting

Post Operative Nausea and Vomiting Clinical Trial

Official title:

Aromatherapy as Prophylaxis for Prevention of Intrathecal Morphine Induced Nausea and Vomiting in Lower Segment Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434340
• Other study ID #: 2017461
• Status: Completed
• Phase: N/A
• Start date: June 26, 2018
• Est. completion date: April 2, 2019

Study information

• Verified date: February 2018
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of combining non pharmacological anti emetic prophylaxis, namely peppermint essential oil to granisetron and dexamethasone in patient who receive intrathecal morphine for lower segment cesarean section. Half of the patient will receive nasal strip containing peppermint essential oil in addition to granisetron and dexamethasone while the other half will only receive granisetron and dexamethasone.

Description:

It is not uncommon to use different group of anti emetic in order to achieve high successful rate in the prevention of opioid induced nausea and vomiting. This study evaluates the effect of combining non pharmacological and pharmacological method to prevent such condition.

Aromatherapy has been used since many years to treat nausea and vomiting. One of the proposed mechanism is by the activation of olfactory receptor when the molecules of essential oil absorb in the mucus lining olfactory epithelium. The signal is then carried by olfactory sensory neuron to the olfactory bulb which filters and send signal to olfactory cortex as well as limbic system to give the feeling of well being.

Granisetron is a serotonin 3 receptor antagonist prevent or treat nausea and vomiting by competitively blocks the action of serotonin at 5-hydroxytryptamine 3 (5HT3) receptors while the mechanism of action of dexamethasone; which is a glucocorticoids is not fully understood.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: April 2, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) I and II.

• Non-smoker.

• BMI =< 40

• Singleton pregnancy

Exclusion Criteria:

• Patient with known allergy to granisetron, dexamethasone, bupivacaine, fentanyl, morphine, paracetamol, celecoxib, ginger oil.

• Patient who has inability to breathe through nose.

• Patient with history of post-operative nausea and vomiting (PONV) or motion sickness

Related Conditions & MeSH terms

• Nausea
• Post Operative Nausea and Vomiting
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Biological:
• Peppermint essential oil
2 drops applied on a nasal strip

Drug:
• Granisetron
1mg intravenous injection
• Dexamethasone
4mg intravenous injection

Locations

Country	Name	City	State
Malaysia	Universiti Kebangsaan Malaysia Medical Centre	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

References & Publications (9)

Allen TK, Jones CA, Habib AS. Dexamethasone for the prophylaxis of postoperative nausea and vomiting associated with neuraxial morphine administration: a systematic review and meta-analysis. Anesth Analg. 2012 Apr;114(4):813-22. doi: 10.1213/ANE.0b013e318247f628. Epub 2012 Feb 17. Review. — View Citation

Carvalho FA, Tenório SB. Comparative study between doses of intrathecal morphine for analgesia after caesarean. Braz J Anesthesiol. 2013 Nov-Dec;63(6):492-9. doi: 10.1016/j.bjane.2013.01.001. Epub 2013 Dec 5. — View Citation

Cooke B, Ernst E. Aromatherapy: a systematic review. Br J Gen Pract. 2000 Jun;50(455):493-6. Review. — View Citation

Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramèr MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. Erratum in: Anesth Analg. 2015 Feb;120(2):494. Anesth Analg. 2014 Mar;118(3):689. — View Citation

Gehling M, Tryba M. Risks and side-effects of intrathecal morphine combined with spinal anaesthesia: a meta-analysis. Anaesthesia. 2009 Jun;64(6):643-51. Review. — View Citation

Hines S, Steels E, Chang A, Gibbons K. Aromatherapy for treatment of postoperative nausea and vomiting. Cochrane Database Syst Rev. 2012 Apr 18;(4):CD007598. doi: 10.1002/14651858.CD007598.pub2. Review. Update in: Cochrane Database Syst Rev. 2018 Mar 10;3:CD007598. — View Citation

Ravindran J. Rising caesarean section rates in public hospitals in Malaysia 2006. Med J Malaysia. 2008 Dec;63(5):434-5. — View Citation

Shanazi M, Farshbaf Khalili A, Kamalifard M, Asghari Jafarabadi M, Masoudin K, Esmaeli F. Comparison of the Effects of Lanolin, Peppermint, and Dexpanthenol Creams on Treatment of Traumatic Nipples in Breastfeeding Mothers. J Caring Sci. 2015 Dec 1;4(4):297-307. doi: 10.15171/jcs.2015.030. eCollection 2015 Dec. — View Citation

Stoicea N, Gan TJ, Joseph N, Uribe A, Pandya J, Dalal R, Bergese SD. Alternative Therapies for the Prevention of Postoperative Nausea and Vomiting. Front Med (Lausanne). 2015 Dec 16;2:87. doi: 10.3389/fmed.2015.00087. eCollection 2015. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of nausea and vomiting	Severity of nausea and vomiting is assessed by direct questioning or spontaneous complaint by patient at three time interval; after institution of spinal anesthesia until prior to being discharged from recovery bay, at 6 hour and 24 hour for 1 day. For nausea, severity is assessed using numerical rating scale (NRS). 0 means no nausea while 10 means worst imaginable nausea. As for vomiting, number of occurrence indicates severity. 1-2 times is considered mild, 3-5 times is moderate and more than 5 times is severe.	24 hours