Analgesia, Obstetrical Clinical Trial
Official title:
Efficacy of Intravenous Paracetamol as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial
Verified date | October 2015 |
Source | Ain Shams Maternity Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Higher Education |
Study type | Interventional |
The aim of this study is to assess whether paracetamol is as effective as pethidine for analgesia during the first stage of labor.
Status | Not yet recruiting |
Enrollment | 104 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Primiparity - Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes) - Maternal age between 20-30 years - Singleton term pregnancy (37-42 weeks of gestation) - Vertex-presenting fetus Exclusion Criteria: - Clinical evidence of cephalopelvic disproportion - Scarred uterus; previous cesarean section, hysterotomy or myomectomy - Medical disorders associated with pregnancy, especially gastritis, peptic ulcer, bronchial asthma or renal impairment - Fetal distress - Receiving any regional or parenteral analgesia before recruitment in the study - Known hypersensitivity to the drug family |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ain Shams Maternity Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The efficacy of intravenous paracetamol to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale. | Assessment is to be done and followed up by the investigator at ½, 1, 2, 3 and 4 hours from drug administration. Scores range from 0 [no pain] to 10 [worst possible pain]. | 4 hours | Yes |
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