UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050981 |
|---|---|
| Receipt number | R000058023 |
| Scientific Title | The effect of hydroxyzine hydrochloride on intrathecal morphine-induced pruritus |
| Date of disclosure of the study information | 2023/05/02 |
| Last modified on | 2023/05/02 19:46:11 |
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Basic information
Public title
The effect of hydroxyzine hydrochloride on intrathecal morphine-induced pruritus for cesarean delivery- A randomized control study
Acronym
The effect of hydroxyzine hydrochloride on intrathecal morphine-induced pruritus for cesarean delivery
Scientific Title
The effect of hydroxyzine hydrochloride on intrathecal morphine-induced pruritus
Scientific Title:Acronym
The effect of hydroxyzine hydrochloride on intrathecal morphine-induced pruritus
Region
| Japan |
Condition
Condition
Cesarean delivery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aime to ascertain the prophylactic effect of intravenous hydroxyzine hydrochloride for intrathecal morphine-induced pruritus among pregnant women undergoing cesarean section.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The severity of pruritus within 24 hours
Key secondary outcomes
Postoperative pain and PONV within 24 hours
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous hydroxyzine hydrochloride 25mg right after delivery of the placenta
Interventions/Control_2
Intravenous 0.9% saline right after delivery of the placenta
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1)Patients did not give consent.
2)Had no time for explanation, (3) used an antihistamine drug, pentazocine before surgery or (4) had an allergy to hydroxyzine, morphine, fentanyl, or bupivacaine.
Patients were excluded if they (1) did not give consent, (2) had no time for explanation, (3) used an antihistamine drug, pentazocine before surgery or (4) had an allergy to hydroxyzine, morphine, fentanyl, or bupivacaine.
Key exclusion criteria
1)Extremely emergent cesarean section
2)Patients who have been using an antihistamine drug or pentazocine before surgery
3)Patients who have an allergy to hydroxyzine, morphine, fentanyl, or bupivacaine
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Uchimura |
Organization
National Hospital Organization Miyakonojo Medical Center
Division name
Department of Anesthesiology
Zip code
885-0014
Address
5033-1 Iwayoshi, Miyakonojo, Miyazaki
TEL
0986-23-4111
syuji_uchimura@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuji |
| Middle name | |
| Last name | Uchimura |
Organization
National Hospital Organization Miyakonojo Medical Center
Division name
Department of Anesthesiology
Zip code
885-0014
Address
5033-1 Iwayoshi, Miyakonojo, Miyazaki
TEL
0986-23-4111
Homepage URL
syuji_uchimura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Miyakonojo Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Miyakonojo Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The National Hospital Organization Miyakonojo Medical Center Institutional Committee on Ethics
Address
5033-1 Iwayoshi, Miyakonojo, Miyazaki
Tel
0986-23-4111
621-kanrika@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
https://site.convention.co.jp/jsca2022/wp/wp-content/uploads/2022/10/jsca2022-general.pdf
Publication of results
Published
Result
URL related to results and publications
https://site.convention.co.jp/jsca2022/wp/wp-content/uploads/2022/10/jsca2022-general.pdf
Number of participants that the trial has enrolled
81
Results
The prophylactic intravenous hydroxyzine hydrochloride did not prevent the severity of intrathecal morphine-induced pruritus among pregnant women undergoing cesarean section.
Results date posted
| 2023 | Year | 05 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Finally, 40 patients in the hydroxyzine hydrochloride group and 41 patients in the control group completed the study. Baseline characteristics(Age:33.8, 31.7 ; p=0.094, BMI:27.7, 27.7; p=0.97) and operative data(operation time:83.1 min., 76.2 min.; p=0.22) showed no statistically significant differences between the two groups.
Participant flow
From February 15, 2021, through March 3, 2022, ninety patients were enrolled. 5 patients declined to participate, 2 patients had no time for explanation due to an emergency and 1 was used pentazocine before caesarean section. 82 patients underwent randomization. In the control group, 1 patient was excluded due to unsuccessful spinal blockade. Finally, 40 patients in the hydroxyzine hydrochloride group and 41 patients in the control group completed the study.
Adverse events
None
Outcome measures
The severity of pruritus between the hydroxyzine hydrochloride group and the control group were no significant difference at 3, 6, 12, and 24 hours after intrathecal administration of morphine(p = 0.23, 0.24, 0.34, 0.91). The postoperative pain score between the hydroxyzine hydrochloride group and the control group at 3, 6, 12, and 24 hours were 2.7 vs 2.3(p = 0.70), 2.3 vs 2.0(p = 0.48), 2.5 vs 1.7(p = 0.228), 2.6 vs 3.1(p = 0.078). There was no significant difference between the two groups at any time point. Although the PONV severity score at 3, 6, 12, and 24 hours were no significant difference between the two groups(0.025 vs 0.22; p=0.42, 0.05 vs 0.32; p= 0.16, 0 vs 0.12; p = 0.055, 0 vs 0), group H at 6, 12 hours tended to have less score than group C.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058023
