Lili Church, MD

ABSTRACT

BACKGROUND: Pain that occurs from perineal laceration or episiotomy during childbirth can be severe and is often undertreated. This randomized double-blind controlled trial was designed to compare the effectiveness and side effects related to 2 common analgesics used in this setting: ibuprofen and acetaminophen with codeine.

POPULATION STUDIED: The study looked at 237 women who delivered vaginally and who had either a third- or fourth-degree perineal laceration or an episiotomy. The trial took place between August 1995 and November 1996 at a tertiary-care teaching and referral center for obstetric care in Vancouver, BC, Canada. Approximately 35% of the women enrolled spoke Cantonese or Mandarin; these women were supplied with consent forms in Chinese script translated by a bilingual nurse. Women were excluded for allergy to either of the study drugs, history of drug dependence, regular use of analgesic drugs, or any medical condition known to be potentially exacerbated by opioids or nonsteroidal anti-inflammatory drugs. Women were also excluded if any major postpartum complication, including postpartum hemorrhage, had occurred. The 2 groups of women did not differ significantly in sociodemographic characteristics or in gravidity and parity. All but 4 of the 237 women enrolled completed the study. The 2 treatment groups did not differ significantly except that the ibuprofen group contained more women who had had forceps delivery.

STUDY DESIGN AND VALIDITY: This study was a randomized, double-blind trial with no placebo control. Randomization was done in blocks of 20 and stratified on the use of forceps, which were postulated to contribute significantly to postpartum pain. Women were randomized within 1 hour after delivery to receive either 400 mg ibuprofen or 600 mg acetaminophen with 60 mg codeine and 30 mg caffeine every 4 hours for 24 hours after birth. The pharmacy allocated the patients to the treatment groups. Women and their nurses were blinded. Women who did not request analgesia were not enrolled.

OUTCOMES MEASURED: The primary outcome measured was severity of pain rated on a 10-cm visual analog scale. Other outcomes evaluated were the number of doses of medication, dosing intervals, treatment failures, side effects, overall level of satisfaction, cost of treatment, and nursing time required for medication administration.

RESULTS: Both groups had similar pain ratings before taking the first dose of analgesic (rating of 3.4 for ibuprofen vs 3.3 for acetaminophen plus codeine plus caffeine) as well as number of medication doses in 24 hours (3.4 vs 3.3) and treatment failures (13.8% vs 16%). Among treatment failures, 78% occurred in women who had had forceps delivery. Subjects receiving ibuprofen experienced fewer side effects (52.4% vs 71.7%, P = .006, number needed to harm = 5.2). Overall satisfaction between the groups did not differ. Ibuprofen ($0.02/tablet) was less expensive than acetaminophen with codeine ($0.05/tablet). Because of the need for additional inventory control, the administration of each dose of the codeine combination took an average of 10 minutes, more time than the administration of ibuprofen.

ABSTRACT

BACKGROUND: Pain that occurs from perineal laceration or episiotomy during childbirth can be severe and is often undertreated. This randomized double-blind controlled trial was designed to compare the effectiveness and side effects related to 2 common analgesics used in this setting: ibuprofen and acetaminophen with codeine.

POPULATION STUDIED: The study looked at 237 women who delivered vaginally and who had either a third- or fourth-degree perineal laceration or an episiotomy. The trial took place between August 1995 and November 1996 at a tertiary-care teaching and referral center for obstetric care in Vancouver, BC, Canada. Approximately 35% of the women enrolled spoke Cantonese or Mandarin; these women were supplied with consent forms in Chinese script translated by a bilingual nurse. Women were excluded for allergy to either of the study drugs, history of drug dependence, regular use of analgesic drugs, or any medical condition known to be potentially exacerbated by opioids or nonsteroidal anti-inflammatory drugs. Women were also excluded if any major postpartum complication, including postpartum hemorrhage, had occurred. The 2 groups of women did not differ significantly in sociodemographic characteristics or in gravidity and parity. All but 4 of the 237 women enrolled completed the study. The 2 treatment groups did not differ significantly except that the ibuprofen group contained more women who had had forceps delivery.

STUDY DESIGN AND VALIDITY: This study was a randomized, double-blind trial with no placebo control. Randomization was done in blocks of 20 and stratified on the use of forceps, which were postulated to contribute significantly to postpartum pain. Women were randomized within 1 hour after delivery to receive either 400 mg ibuprofen or 600 mg acetaminophen with 60 mg codeine and 30 mg caffeine every 4 hours for 24 hours after birth. The pharmacy allocated the patients to the treatment groups. Women and their nurses were blinded. Women who did not request analgesia were not enrolled.

OUTCOMES MEASURED: The primary outcome measured was severity of pain rated on a 10-cm visual analog scale. Other outcomes evaluated were the number of doses of medication, dosing intervals, treatment failures, side effects, overall level of satisfaction, cost of treatment, and nursing time required for medication administration.

RESULTS: Both groups had similar pain ratings before taking the first dose of analgesic (rating of 3.4 for ibuprofen vs 3.3 for acetaminophen plus codeine plus caffeine) as well as number of medication doses in 24 hours (3.4 vs 3.3) and treatment failures (13.8% vs 16%). Among treatment failures, 78% occurred in women who had had forceps delivery. Subjects receiving ibuprofen experienced fewer side effects (52.4% vs 71.7%, P = .006, number needed to harm = 5.2). Overall satisfaction between the groups did not differ. Ibuprofen ($0.02/tablet) was less expensive than acetaminophen with codeine ($0.05/tablet). Because of the need for additional inventory control, the administration of each dose of the codeine combination took an average of 10 minutes, more time than the administration of ibuprofen.

ABSTRACT

BACKGROUND: Pain that occurs from perineal laceration or episiotomy during childbirth can be severe and is often undertreated. This randomized double-blind controlled trial was designed to compare the effectiveness and side effects related to 2 common analgesics used in this setting: ibuprofen and acetaminophen with codeine.

POPULATION STUDIED: The study looked at 237 women who delivered vaginally and who had either a third- or fourth-degree perineal laceration or an episiotomy. The trial took place between August 1995 and November 1996 at a tertiary-care teaching and referral center for obstetric care in Vancouver, BC, Canada. Approximately 35% of the women enrolled spoke Cantonese or Mandarin; these women were supplied with consent forms in Chinese script translated by a bilingual nurse. Women were excluded for allergy to either of the study drugs, history of drug dependence, regular use of analgesic drugs, or any medical condition known to be potentially exacerbated by opioids or nonsteroidal anti-inflammatory drugs. Women were also excluded if any major postpartum complication, including postpartum hemorrhage, had occurred. The 2 groups of women did not differ significantly in sociodemographic characteristics or in gravidity and parity. All but 4 of the 237 women enrolled completed the study. The 2 treatment groups did not differ significantly except that the ibuprofen group contained more women who had had forceps delivery.

STUDY DESIGN AND VALIDITY: This study was a randomized, double-blind trial with no placebo control. Randomization was done in blocks of 20 and stratified on the use of forceps, which were postulated to contribute significantly to postpartum pain. Women were randomized within 1 hour after delivery to receive either 400 mg ibuprofen or 600 mg acetaminophen with 60 mg codeine and 30 mg caffeine every 4 hours for 24 hours after birth. The pharmacy allocated the patients to the treatment groups. Women and their nurses were blinded. Women who did not request analgesia were not enrolled.

OUTCOMES MEASURED: The primary outcome measured was severity of pain rated on a 10-cm visual analog scale. Other outcomes evaluated were the number of doses of medication, dosing intervals, treatment failures, side effects, overall level of satisfaction, cost of treatment, and nursing time required for medication administration.

RESULTS: Both groups had similar pain ratings before taking the first dose of analgesic (rating of 3.4 for ibuprofen vs 3.3 for acetaminophen plus codeine plus caffeine) as well as number of medication doses in 24 hours (3.4 vs 3.3) and treatment failures (13.8% vs 16%). Among treatment failures, 78% occurred in women who had had forceps delivery. Subjects receiving ibuprofen experienced fewer side effects (52.4% vs 71.7%, P = .006, number needed to harm = 5.2). Overall satisfaction between the groups did not differ. Ibuprofen ($0.02/tablet) was less expensive than acetaminophen with codeine ($0.05/tablet). Because of the need for additional inventory control, the administration of each dose of the codeine combination took an average of 10 minutes, more time than the administration of ibuprofen.

BACKGROUND: There is no consensus concerning the frequency of screening Pap tests in postmenopausal women. High false-positive rates for abnormal test results in this group increase cost, risk, and discomfort of invasive procedures, and anxiety. In postmenopausal women, the majority of abnormal Pap test results are composed of atyptical squamous cells of uncertain significance (ASCUS) and data conflict as to whether hormone replacement therapy (HRT) has any effect on its development.

POPULATION STUDIED: From 20 outpatient clinical centers, 2561 postmenopausal women were recruited from screening interviews of 68,561 women. The criteria for entering the study were age younger than 80 years, an intact uterus, and a normal Pap test result at baseline. The mean age was 66.7 years, and all had coronary artery disease.

STUDY DESIGN AND VALIDITY: This is a 2-part study using a prospective cohort design to calculate the incidence of cytologic abnormalities and a randomized double-blinded placebo-controlled design to evaluate the effect of HRT. Cervical tests were performed annually in participating clinics, with all tests evaluated at the same central pathology laboratory. Abnormal Pap test results were managed in the conventional manner. For each cytologic abnormality the final histologic diagnosis was considered normal only if all follow-up tests were normal or proved negative by colposcopy. In a second aspect of the study, the participants were randomly assigned to receive placebo or the combination of oral conjugated equine estrogens 0.625 mg plus medroxy- progesterone acetate 2.5 mg daily.

OUTCOMES MEASURED: The primary outcomes were the incidence over 2 years of new cervical cytologic abnormalities (ASCUS, atypical glandular cells of undetermined significance [AGCUS], low-grade squamous intraepithelial lesion [LGSIL], and high-grade squamous intraepithelial lesion [HGSIL]), and final histologic diagnoses, with the main outcome being the actual diagnosis of cervical cancer.

RESULTS: The incidence of new cytologic abnormalities in the first year was 78 women (3%), and in the second year there were an additional 32 women (1.4%). The total incidence of abnormal Pap results for the 2 years following a normal test was 110, or 2.3%. Most of Pap abnormalities were reported as ASCUS (67.3%) or AGCUS (21%); 10.9% were LGSIL; and 0.9% were HGSIL. More important, no women in the first year were found to have high-grade cervical intraepithelial neoplasia (CIN). In the second year, one patient had a CIN grade 1 or 2 lesion. Therefore, the positive predictive value of any abnormal test identified 1 year after an initial normal test was 0% (95% confidence interval [CI], 0%-5%) and within 2 years was 0.9% (95% CI, 0%-3%). Hormone therapy did not show any significant effect on the incidence of cervical cytologic abnormalities.

BACKGROUND: There is no consensus concerning the frequency of screening Pap tests in postmenopausal women. High false-positive rates for abnormal test results in this group increase cost, risk, and discomfort of invasive procedures, and anxiety. In postmenopausal women, the majority of abnormal Pap test results are composed of atyptical squamous cells of uncertain significance (ASCUS) and data conflict as to whether hormone replacement therapy (HRT) has any effect on its development.

POPULATION STUDIED: From 20 outpatient clinical centers, 2561 postmenopausal women were recruited from screening interviews of 68,561 women. The criteria for entering the study were age younger than 80 years, an intact uterus, and a normal Pap test result at baseline. The mean age was 66.7 years, and all had coronary artery disease.

STUDY DESIGN AND VALIDITY: This is a 2-part study using a prospective cohort design to calculate the incidence of cytologic abnormalities and a randomized double-blinded placebo-controlled design to evaluate the effect of HRT. Cervical tests were performed annually in participating clinics, with all tests evaluated at the same central pathology laboratory. Abnormal Pap test results were managed in the conventional manner. For each cytologic abnormality the final histologic diagnosis was considered normal only if all follow-up tests were normal or proved negative by colposcopy. In a second aspect of the study, the participants were randomly assigned to receive placebo or the combination of oral conjugated equine estrogens 0.625 mg plus medroxy- progesterone acetate 2.5 mg daily.

OUTCOMES MEASURED: The primary outcomes were the incidence over 2 years of new cervical cytologic abnormalities (ASCUS, atypical glandular cells of undetermined significance [AGCUS], low-grade squamous intraepithelial lesion [LGSIL], and high-grade squamous intraepithelial lesion [HGSIL]), and final histologic diagnoses, with the main outcome being the actual diagnosis of cervical cancer.

RESULTS: The incidence of new cytologic abnormalities in the first year was 78 women (3%), and in the second year there were an additional 32 women (1.4%). The total incidence of abnormal Pap results for the 2 years following a normal test was 110, or 2.3%. Most of Pap abnormalities were reported as ASCUS (67.3%) or AGCUS (21%); 10.9% were LGSIL; and 0.9% were HGSIL. More important, no women in the first year were found to have high-grade cervical intraepithelial neoplasia (CIN). In the second year, one patient had a CIN grade 1 or 2 lesion. Therefore, the positive predictive value of any abnormal test identified 1 year after an initial normal test was 0% (95% confidence interval [CI], 0%-5%) and within 2 years was 0.9% (95% CI, 0%-3%). Hormone therapy did not show any significant effect on the incidence of cervical cytologic abnormalities.

BACKGROUND: There is no consensus concerning the frequency of screening Pap tests in postmenopausal women. High false-positive rates for abnormal test results in this group increase cost, risk, and discomfort of invasive procedures, and anxiety. In postmenopausal women, the majority of abnormal Pap test results are composed of atyptical squamous cells of uncertain significance (ASCUS) and data conflict as to whether hormone replacement therapy (HRT) has any effect on its development.

POPULATION STUDIED: From 20 outpatient clinical centers, 2561 postmenopausal women were recruited from screening interviews of 68,561 women. The criteria for entering the study were age younger than 80 years, an intact uterus, and a normal Pap test result at baseline. The mean age was 66.7 years, and all had coronary artery disease.

STUDY DESIGN AND VALIDITY: This is a 2-part study using a prospective cohort design to calculate the incidence of cytologic abnormalities and a randomized double-blinded placebo-controlled design to evaluate the effect of HRT. Cervical tests were performed annually in participating clinics, with all tests evaluated at the same central pathology laboratory. Abnormal Pap test results were managed in the conventional manner. For each cytologic abnormality the final histologic diagnosis was considered normal only if all follow-up tests were normal or proved negative by colposcopy. In a second aspect of the study, the participants were randomly assigned to receive placebo or the combination of oral conjugated equine estrogens 0.625 mg plus medroxy- progesterone acetate 2.5 mg daily.

OUTCOMES MEASURED: The primary outcomes were the incidence over 2 years of new cervical cytologic abnormalities (ASCUS, atypical glandular cells of undetermined significance [AGCUS], low-grade squamous intraepithelial lesion [LGSIL], and high-grade squamous intraepithelial lesion [HGSIL]), and final histologic diagnoses, with the main outcome being the actual diagnosis of cervical cancer.

RESULTS: The incidence of new cytologic abnormalities in the first year was 78 women (3%), and in the second year there were an additional 32 women (1.4%). The total incidence of abnormal Pap results for the 2 years following a normal test was 110, or 2.3%. Most of Pap abnormalities were reported as ASCUS (67.3%) or AGCUS (21%); 10.9% were LGSIL; and 0.9% were HGSIL. More important, no women in the first year were found to have high-grade cervical intraepithelial neoplasia (CIN). In the second year, one patient had a CIN grade 1 or 2 lesion. Therefore, the positive predictive value of any abnormal test identified 1 year after an initial normal test was 0% (95% confidence interval [CI], 0%-5%) and within 2 years was 0.9% (95% CI, 0%-3%). Hormone therapy did not show any significant effect on the incidence of cervical cytologic abnormalities.