Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy

Cairo University (CU)

Status and phase: Unknown; Phase 3

Conditions: Hysteroscopy

Treatments: Drug: Tramadol; Drug: Celecoxib; Drug: Placebo 1; Drug: Placebo 2

Study type: Interventional

Funder types: Other

Identifiers

NCT02736071

Hyst 8

Details and patient eligibility

About

Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.

Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).

Full description

Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.

All procedures will be scheduled to be done postmenstrual or after cessation of bleeding in case of metrorrhagia and will be done in the lithotomy position. The procedures will be performed using 30 degree angle 2.7 mm rigid hysteroscope with a 5mm outer diameter continuous flow hysteroscope with a 5 French working channel, a Teknolight 180 XA light source, and a Xenon high density fibre optic light cable 3.5mm, 2300mm Light cable without adaptors and a T Camera teknocam 2000S pro. All the equipment are provided by Tekno GmbH and Co®, Germany.

Vaginoscopic approach will be used for insertion of the hysteroscope in all cases. The hysteroscope will be gently introduced into the uterine cavity after visualization of the cervix and identification of the external os. Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS). VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain. Patients will also be asked to report any side effects. The main outcome measure will be patients' pain perception during the procedure.

Statistics:

Quantitative data will be statistically represented in terms of mean ± standard deviation (± SD) while categorical data will be represented as frequency and percentage. Comparison of quantitative data will be done using ANOVA test for independent samples while categorical data will be compared using Chi squared test or Fisher exact test when appropriate. A probability value (p value) less than 0.05 will be considered significant.

Sample size calculation:

To the best of researchers knowledge this is the first trial to investigate the role of Celecoxib and oral Tramadol in reducing outpatient operative hysteroscopy associated pain, with no previous data to calculate the sample size with. Data from studies on diagnostic hysteroscopy cannot be applied because operative hysteroscopies need more manipulations and cause more pain. Assuming that the response will be normally distributed, the sample size is calculated to detect a mean difference of 1 unit between Tramadol and Celecoxib pain scores during the procedure (lower difference are not considered clinically relevant) using VAS assuming that the within group standard deviation will be 2. Investigators will need to study 64 cases in each group to be able to reject the null hypothesis that the population means of the Tramadol and Celecoxib are equal with probability (power) 0.8. Investigators added 6 cases to each arm accounting for any missing data and procedure failure ending in 70 cases in each group. The Type I error probability associated with this test of this null hypothesis is 0.05 using Student's t test for independent samples. Sample size calculation is done using Stats Direct statistical software version 2.7.2 for microsoft Windows, Stats Direct Ltd., Cheshire, UK.

Enrollment: 210 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for operative outpatient hysteroscopy, indications will include endometrial biopsy, polypectomy, septum resection, intra-uterine device removal and adhesiolysis.

Exclusion criteria

• Submucous myomas.
• Known medical disorders like uncontrolled diabetes, hypertension, cardiac, renal or liver disease.
• Gastritis or peptic ulcer.
• Allergy to Tramadol or Celecoxib.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 3 patient groups, including a placebo group

Celecoxib

Active Comparator group

Description:

Women will receive oral Celecoxib 200mg 2 hours before the procedure

Treatment:

Drug: Celecoxib

Tramadol

Active Comparator group

Description:

Women will receive oral Tramadol 100 mg 2 hours before the procedure

Treatment:

Drug: Tramadol

Placebo

Placebo Comparator group

Description:

Women will receive an oral placebo similar to Tramadol and an oral placebo similar to Celecoxib 2 hours before the procedure

Treatment:

Drug: Placebo 2

Drug: Placebo 1