Paracetamol for Intrapartum Analgesia
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|ClinicalTrials.gov Identifier: NCT02578251|
Recruitment Status : Unknown
Verified October 2015 by Hamdy Bakry Mohye Soliman El Kinawy, Ain Shams Maternity Hospital.
Recruitment status was: Not yet recruiting
First Posted : October 16, 2015
Last Update Posted : October 16, 2015
Ain Shams Maternity Hospital
Information provided by (Responsible Party):
Hamdy Bakry Mohye Soliman El Kinawy, Ain Shams Maternity Hospital
The aim of this study is to assess whether paracetamol is as effective as pethidine for analgesia during the first stage of labor.
|Condition or disease||Intervention/treatment||Phase|
|Analgesia, Obstetrical||Drug: Paracetamol Drug: Pethidine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of Intravenous Paracetamol as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2016|
Patients will receive paracetamol intravenously (1 g in 100 mL) over 15 minutes (single dose), as an analgesic during the first stage of labor, given by a member of the study team.
Active Comparator: Pethidine
Slow intravenous administration of pethidine, 50 mg to be diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team.
Primary Outcome Measures :
- The efficacy of intravenous paracetamol to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale. [ Time Frame: 4 hours ]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].
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