Pruritus Caused by Drug
Conditions
Brief summary
This study compares the incidence of pruritus (itching) requiring treatment between two doses of intrathecal morphine (0.1 mg vs 0.2 mg) when used for spinal anesthesia during cesarean section. The study aims to determine if the lower dose (0.1 mg) can reduce pruritus incidence while maintaining adequate pain relief.
Detailed description
Spinal anesthesia is a standard technique for cesarean section. Intrathecal morphine (ITM) provides prolonged and effective analgesia but may cause adverse events including pruritus, nausea, vomiting, and respiratory depression. Current practice at Srinagarind Hospital uses ITM 0.2 mg for spinal anesthesia in cesarean section. This study investigates whether reducing the ITM dose to 0.1 mg can decrease pruritus incidence while preserving analgesic effectiveness.
Interventions
DRUGMorphine Sulfate
intrathecal administered morphine
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
They are unaware of type of drug administered.
Intervention model description
Arm 1: intrathecal morphine (ITM) 0.1 mg Arm 2 intrathecal morphine (ITM) 0.2 mg
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
• Pregnant women aged 18-45 years * Full-term pregnancy * Scheduled for non-emergency cesarean section * ASA physical status I-III * Non-complicated pregnancy
Exclusion criteria
* Contraindication to spinal anesthesia or study drugs * Refusal to participate in the study * BMI ≥ 40 kg/m² * History of systemic skin disease or current itchy skin condition * Use of antihistamines or anti-pruritic medications within 3 days prior to surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pruritus requiring treatment [Time Frame: 24 hours post-operatively] | 24 hours | * Percentage of participants requiring treatment for pruritus within 24 hours after spinal anesthesia * Measured using numerical rating scale (0-10), with treatment indicated for score ≥4 * Percentage of participants requiring treatment for pruritus within 24 hours after spinal anesthesia * Measured using numerical rating scale (0-10), with treatment indicated for score ≥4 * Percentage of participants requiring treatment for pruritus within 24 hours after spinal anesthesia * Measured using numerical rating scale (0-10), with treatment indicated for score ≥4 |
Countries
Thailand
Contacts
Primary ContactThepakorn Sathitkarnbmanee
Backup ContactSirirat Tribuddharat
Outcome results
None listed