Key result
Intrathecal midazolam 2 mg significantly prolonged the duration of postoperative analgesia compared to placebo (357.6 vs 201.5 minutes, p<0.01) in patients with pregnancy-induced hypertension.
Why the study?
Does intrathecal midazolam improve postoperative analgesia in pregnancy-induced hypertensive patients undergoing elective caesarean section?
RCT (n=60)
Double-blind
Computer-generated randomization list
No
Does intrathecal midazolam improve postoperative analgesia in pregnancy-induced hypertensive patients undergoing elective caesarean section?
Absolute Event Rate: 357.6% vs 201.5%
p-value: p=<0.01
Intrathecal midazolam 2 mg added to bupivacaine significantly prolongs postoperative analgesia and reduces the incidence of hypotension in patients with pregnancy-induced hypertension undergoing elective caesarean section.
May support intrathecal midazolam addition for prolonged analgesia in PIH cesarean delivery; extends spinal adjunct evidence to hypertensive pregnancies.
Background: A pain-free postoperative period is essential following a caesarean section so new mothers may care for and bond with their neonates. Intrathecal adjuvants are often administered during this procedure to provide significant analgesia, but they may also have bothersome side effects. Intrathecal midazolam produces effective postoperative analgesia with no significant side effects. Objectives: This prospective, randomized, double-blind study was designed to compare the analgesic efficacy and safety of intrathecal midazolam vs. plain bupivacaine as an adjunct to bupivacaine in pregnancy-induced hypertension patients scheduled for elective caesarean section. Methods: Sixty patients diagnosed with pregnancy-induced hypertension on regular treatment who were scheduled for a caesarean section were randomly allocated into two groups: a control group (Group BC, n = 30) and a midazolam group (Group BM, n = 30). Both groups received 10 mg (2 mL) of 0.5% hyperbaric bupivacaine. Group BC received 0.4 mL of distilled water, while group BM received 0.4 mL (2 mg) of midazolam intrathecally. The duration of postoperative analgesia, analgesic requirements during the first 24 hours after surgery, onset times and durations of sensory and motor blocks, incidence of hypotension, vasopressor requirements, and side effects were recorded. Results: Postoperative analgesia was significantly longer in the midazolam group compared to the control group (201.5 minutes vs. 357.6 minutes). The mean onset times of the sensory and motor blocks were significantly faster (P < 0.01) in the midazolam group compared to the control group. The mean times to attain the maximum sensory level and motor blocks were also significantly faster in the midazolam group compared to the control group (P < 0.05). The incidence of hypotension was 6.6% in the midazolam group and 36.6% in the control group, which was highly significant. In addition, the number of patients with side effects was significantly lower in the midazolam group compared to the control group. Conclusions: Intrathecal midazolam 2 mg provides significantly longer and effective postoperative analgesia with no side effects.
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Dodawad et al. (2016) conducted an RCT in Pregnancy-induced hypertension (n=60). Intrathecal midazolam vs. Distilled water (placebo) was evaluated on Duration of postoperative analgesia (p=<0.01). Intrathecal midazolam 2 mg significantly prolonged the duration of postoperative analgesia compared to placebo (357.6 vs 201.5 minutes, p<0.01) in patients with pregnancy-induced hypertension.
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