Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting

NCT ID: NCT03434340

Last Updated: 2019-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-26

Study Completion Date

2019-04-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post Operative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Granisetron & Dexamethasone & Peppermint essential oil

Granisetron 1mg and Dexamethasone 4mg administer as intravenous injection once right after delivery of newborn followed by Peppermint essential oil 2 drops on nasal strip applied for 6 hours

Group Type EXPERIMENTAL

Peppermint essential oil

Intervention Type BIOLOGICAL

2 drops applied on a nasal strip

Granisetron

Intervention Type DRUG

1mg intravenous injection

Dexamethasone

Intervention Type DRUG

4mg intravenous injection

Granisetron & Dexamethasone

Granisetron 1mg and Dexamethasone 4mg administer as intravenous injection once right after delivery of newborn

Group Type ACTIVE_COMPARATOR

Granisetron

Intervention Type DRUG

1mg intravenous injection

Dexamethasone

Intervention Type DRUG

4mg intravenous injection

Interventions

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Peppermint essential oil

2 drops applied on a nasal strip

Intervention Type BIOLOGICAL

Granisetron

1mg intravenous injection

Intervention Type DRUG

Dexamethasone

4mg intravenous injection

Intervention Type DRUG

Other Intervention Names

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YoungLiving®, 100% pure Peppermint essential oil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universiti Kebangsaan Malaysia Medical Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Assoc Prof Dr Raha Abdul Rahman

Role: PRINCIPAL_INVESTIGATOR

Consultant Anaesthesiologist

Locations

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Universiti Kebangsaan Malaysia Medical Centre

Cheras, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

References

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

Reference Type BACKGROUND
PMID: 19803313 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22513952 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26734609 (View on PubMed)

Carvalho FA, Tenorio 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.

Reference Type BACKGROUND
PMID: 24565347 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22344239 (View on PubMed)

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. doi: 10.1111/j.1365-2044.2008.05817.x.

Reference Type BACKGROUND
PMID: 19462494 (View on PubMed)

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, Tramer 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.

Reference Type BACKGROUND
PMID: 24356162 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26744729 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10962794 (View on PubMed)

Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.

Reference Type DERIVED
PMID: 34002866 (View on PubMed)

Other Identifiers

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2017461

Identifier Type: -

Identifier Source: org_study_id

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