Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients (TAH)
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ClinicalTrials.gov Identifier: NCT01055236 |
Recruitment Status :
Completed
First Posted : January 25, 2010
Last Update Posted : March 29, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pruritus Nausea Vomiting | Drug: hydroxyzine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Hydroxyzine for the Prevention of Pruritus and Nausea Vomiting From Spinal Morphine in Patients Having Transabdominal Hysterectomy Under Combined Spinal-general Anesthesia: A Randomized Control Trial |
Study Start Date : | August 2007 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | October 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: hydroxyzine |
Drug: hydroxyzine
75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.
Other Name: atarax |
Placebo Comparator: placebo
starch tablet
|
Drug: hydroxyzine
75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.
Other Name: atarax |
- successful treatment of pruritus [ Time Frame: 48 hour ]
- successful treatment of nausea or vomiting [ Time Frame: 48 hours ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ASA classification 1-2
- Age from 18-60 years old
- Body mass index (BMI) below 35
- Accepted combined spinal-general anesthesia
Exclusion Criteria:
- Previous history of Hydroxyzine allergy
- Underlying diseases of urticaria, pruritus, nausea vomiting and motion sickness
- Previous complications of procedure or anesthesia

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055236
Thailand | |
Siriraj Hospital | |
Bangkoknoi, Bangkok, Thailand, 10700 |
Study Director: | Dr. Phuriphong Songarj, MD | Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand |
Responsible Party: | Dr. Phuriphong Songarj, Department of Anesthesiology |
ClinicalTrials.gov Identifier: | NCT01055236 |
Other Study ID Numbers: |
168/2550(EC1) |
First Posted: | January 25, 2010 Key Record Dates |
Last Update Posted: | March 29, 2010 |
Last Verified: | December 2008 |
sedation |
Pruritus Nausea Vomiting Signs and Symptoms, Digestive Skin Diseases Skin Manifestations Hydroxyzine Antipruritics |
Dermatologic Agents Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |