A Phase 4 interventional study of Morphine Sulfate in Pruritus Caused by Drug, sponsored by Khon Kaen University. Recruiting at 2 sites in Thailand. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Khon Kaen University · Phase 4, Interventional, and Treatment
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.
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.
Inclusion Criteria: • Pregnant women aged 18-45 years
Exclusion Criteria:
Participants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.1 mg intrathecally
Drug: Morphine Sulfate
Participants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.2 mg intrathecally
Drug: Morphine Sulfate
intrathecal administered morphine
Incidence of pruritus requiring treatment [Time Frame: 24 hours post-operatively]
* 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
Time frame: 24 hours
Plan to share: No
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Khon Kaen University