Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy

Instituto Mexicano del Seguro Social

Status and phase: Completed; Phase 3

Conditions: Hemorrhoids

Treatments: Drug: Placebo; Drug: Metronidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02328144

R-2013-1301-71

Details and patient eligibility

About

Hemorrhoidal disease occurs in 50% of people over 40 years old and is the most common cause of anorectal surgery. One of the complications of hemorrhoidectomy is pain, which is a difficult symptom to appreciate and assess, by its frequent and large variations in sensitivity in each patient. Many studies have been done to reduce patient postoperative pain, but there is no ideal method. The application of both oral and topical metronidazole has shown to decrease pain following hemorrhoidectomy, but its use is not standardized.

The investigators evaluated the effect of oral administration of metronidazole versus homologated placebo in pain control after hemorrhoidectomy

Full description

Objective: Evaluate the effect of oral administration of metronidazole versus homologated placebo in pain control after hemorrhoidectomy.

Material and methods: Controlled clinical trial, composed of 44 patients in a randomized manner, realized at the Coloproctology, Western Medical Center, Mexican Institute of Social Security. Referred beneficiaries adults were included, of either sex, who merited elective hemorrhoidectomy for hemorrhoidal disease grades III-IV using Ferguson's technique. They were assigned to receive metronidazole (study group) or homologated (control group) and the randomization was conducted by sealed envelopes and subsequently. We collected demographic and clinical variables. Postoperative pain was assessed by visual analog scale at 6 and 12hrs, 1, 4, 7 and 14 days; additional analgesic use; complications; return to normal activity and patient satisfaction; also were measured, in a blood sample after surgery and 12 hrs later, interleukin 6 and 10.

The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hemorrhoidal disease grade III and IV
• Informed consent

Exclusion criteria

• Pregnancy
• Lactation
• Other anorectal disease
• Previous anorectal
• hypersensibility to metronidazole

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Metronidazole

Active Comparator group

Description:

22 patients received oral metronidazole 500mg 3 times for day for 7 days

Treatment:

Drug: Metronidazole

Placebo

Placebo Comparator group

Description:

22 patients received oral placebo 500mg 3 times for day for 7 days

Treatment:

Drug: Placebo